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warningletter

Software Warning Letters

Recipient: LifeScan Inc.Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers Date: 12/7/20055 Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training...
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Recipient:Rite-Dent Manufacturing CorpProduct:Alginate impression material, zinc phosphate cement, polycarboxylate cement and other dental OTC devices Date: 12/2/05 Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain...
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Recipient: Shelhigh Inc.Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices Date:12/14/05 Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive...
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Recipient: Gambro Dasco S.p.A.Product:Electromechanical dialysis control systems Date: 1/5/06 Letter acknowledges receipt of firm’s Oct. 24, 2005, response to FDA 483 but deems it inadequate. Letter notes that until alleged violations are corrected, the FDA may take steps to keeping imported devices in detention. Letter also includes alleged reporting violations. For example, review of the...
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Recipient:Guidant CorpProduct: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer Date:9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended...
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Recipient: Visual Telecommunications NetworkProduct: ViTelCare Trutle Home Patient Monitoring Systems Date: 9/13/05 Software used in the Turtle 600 and Turtle 800 devices has not been validated and a risk analysis has not been conducted for the finished devices [21 CFR 820.30(g)]. FDA District: Baltimore District Office
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/docs/GlucoseMeterFDASafetyAlert102605.pdf
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Recipient: Tepnel Diagnostics Inc.Product:Elucigene genetic assays Date: 8/26/05 FDA District: New England District OfficeBased on information on your website, these devices do not adhere to the restrictions on the sale, distribution, and use of ASRs. Your website makes specific analytical and performance claims such as that your devices can detect multiple mutations per device and...
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Recipient: Boston Scientific Corp.Product:Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents and Symmetry balloon dilation catheters Date: 8/10/05 Failure to analyze processes, work operations and other sources of quality data to identify existing and potential causes of non-conforming product as required by 21 CFR 820.100(a)(1). For example, we observed the release and actual...
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Recipient: Uroplasty Inc.Product: Investigational devices Date: 7/19/05 The inspectional report notes that review of subject records across five (5) investigational sites revealed that study procedures were initiated on 30 subjects prior to obtaining the informed consent of these individuals as required by the regulations at 21 CFR Part 50. The inspectional report further notes that...
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Recipient: Hitachi Medical Systems America Inc.Product: Magnetic Resonance Imaging Systems Date: 7/13/05 On April 20, 2004, your firm issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Your...
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Recipient:Con-Med Corp.Product: Irrigation pumps, hand pieces and surgical drills Date: 6/29/05 Software flags were added to rechargeable batteries after complaints were received referencing the battery’s depletion during surgery. No verification or validation of this corrective action was conducted. FDA District: Florida District Office
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Recipient: Millennium Dental Technologies IncProduct: Medical devices Date: 6/7/05 Our inspection found the following device QSR deficiencies Software used as part of the quality system has not been validated for its intended use according to an established protocol. Specifically, you are using a software system for your procedures that allows procedures to have inconsistent effective,...
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Recipient: Robert Hostoffer D.O.-Allergy and Immunology AssociatesProduct: Investigational biologics product Date: 6/6/05 You failed to collect the paper diary or electronic diary data as required by the protocol. The protocol stated that the paper diary was to be reviewed during the subject’s periodic visits with the clinical investigator (every 3-4 weeks) and that the electronic...
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Recipient: C & M Oxyfill LLC.Product: Compressed Oxygen USP Date: 5/26/05 Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your firm has not performed any equipment qualification on the “mobile” cryogenic pumping system which transfills your Compressed...
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Recipient: BioImageneProduct: PATHIAM software Date: 5/25/05 According to your website, PATHIAM is “a hardware-independent, Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained (IHC-stained) slides from any computer via the Internet.” PATHIAM is a device as that term is defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S .C. 321(h))...
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Recipient: Electrologic of America Inc.Product: Electrical muscle stimulator stationary bicycles Date: 5/9/05 Failure to verify, validate and create a design history file when design changes were made to the StimMaster electrical muscle stimulation stationary bicycle [21 CFR 820.30(i) and (j)]. Engineering Change Notice, dated 11/1/02, states that four inches were removed from the front of...
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Recipient: Philips Medizin Systeme GmbhProduct: IntelliView patient bedside monitors Date: 5/6/05 CAPA investigation 4921 for complaints M2003-009925 and M2003-010130 received from the same hospital regarding a failure in the arrhythmia analysis software was not further investigated to determine whether similar defects in heart rate monitoring were reported by other facilities. Documentation shows the hazard/ risk...
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Recipient: Pace Tech Inc.Product: Stationary and portable patient monitors Date: 4/29/05 Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct...
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Recipient: Inoveon Corp.Product: Diabetic Retinopathy 3DT System Date: 4/27/05 Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include risk analysis, as required by 21 CFR 820.30(g) [FDA 483, Item 15]. For example, a formal risk analysis of the...
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Recipient: Digicare Biomedical Technology Inc.Product:Pulse oximeters and multiparameter patient monitors Date: 4/26/05 However, your firm lacked major steps for effective internal audits, including design control, software validation, corrective and preventive action (CAPA), and Electrostatic Discharge (ESD) reduction activities. Also, the individual conducting the audits lacks the necessary training and experience to conduct such audits and...
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Recipient: Tosoh Bioscience Inc.Product: Immunoassay diagnostic packs and immunoassay systems Date: 3/22/05 Specifically, our inspections revealed that on or about March 27, 2003, your firm was notified by Tosoh Corporation, Tokyo, Japan that a new software revision, version 3.12, was being released to correct washing errors in the analyzer that resulted in discrepant troponin results....
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Recipient: Alternative Health & Herbs RemediesProduct: Squaw Vine, Parsley Herb, Mistletoe (European) and other tinctures Date: 3/17/05 Failure to exercise strict controls over labeling issued for use in drug product labeling operations [21 CFR 211.125(a)]. Specifically, your firm currently does not issue labels, review them for accuracy, or reconcile them; any extra labels from a...
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Recipient: William Gray M.D. – Swedish Medical CenterProduct: Investigational devices Date: 3/16/05 In response your written response, you claim that investigators will continue to work with management and staff to assure protocol adherence. Also, the department has installed new software that provides a check-list for study protocol required procedures. This change should assist you in...
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Recipient: ITO Co. Ltd.Product: US- 100 Portable Ultrasound Therapy Unit, SW-180 Shortwave Therapy Unit, TM-300 Traction Section and other physiotheraphy equipment Date: 3/7/05 Failure to submit a written report to FDA of a correction or removal initiated by the manufacturer to reduce a risk to health by the device, as required by 21 CFR 806.10....
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Recipient: The Byran Co. Inc.Product: Implantable surgical spine screws and rods Date: 2/3/05 Software validation activities for your automated computer system used as part of production have not been performed or documented for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, the software used for setting the specifications...
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Recipient: John Marcum M.D. – Childrens Hospital Los AngelesProduct: Investigational device Date: 1/27/05 Records relating to correspondence with the IRB and sponsor, including required reports, are not all complete. For instance, there is no correspondence demonstrating that the sponsor and IRB were notified of all adverse events and serious adverse events, including the nine infections...
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Recipient: GE Healthcare TechnologiesProduct: Diagnostic x-ray system Date: 1/19/05 Failure to respond constitutes a violation of the Act, Sections 538(a)(2) and 538(a)(4) of Sub-chapter C – Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968). Failure to promptly correct this violation can result in regulatory action being initiated by...
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Company: Cincinnati Sub-Zero ProductsProduct: Class II hypo/hyperthermic machines Date: 1/10/05 Your Customer Communication Procedure states the “technical service manager or alternate shall document the analysis and conclusions of inquiry.” The procedure also states that “if no analysis is required, the technical service manager or alternate shall document the reason” and it should be in the...
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Company:Cyberonics Inc.Product: Vagus Nerve Stimulator Date: 12/22/04 During an inspection of your firm’s manufacturing operations located in Houston, Texas, on July 12 through September 15, 2004, United States Food and Drug Administration (FDA) Investigator, Ellen J. Tave, determined that your firm manufactures the Vagus Nerve Stimulator (VNS), an implanted generator that is indicated for use...
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Company: Precision Piece Parts IncProduct:. Ilio-sacral bone screws Date: 12/15/2004 You failed to validate the original and subsequent changes to computer software used to control automated production and quality system operations, as required by 21 CFR 820.70(i). [See, for example, FDA483 observations 18 and 19.]. FDA District: Detroit District Office
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Company: Sooil Development Co. Ltd.Product:Insulin infusion pump Date: 11/24/04 Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report...
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Company: Ortek AGProduct: Shoulder, hip and knee prostheses Date: 11/19/04 Failure to validate computer software for its intended use for computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, the software used to control the automated _____ used to produce medical...
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Company: Nuclear Cardio Systems Inc.Product: Emission computed tomography systems Date: 11/17/04 In addition, our investigators reviewed _____ of your firm’s service reports. _____ of these reports appeared to meet the definition of a complaint [21 CFR 820.3(b)]; however, none of these were considered by you to be complaints and were not included in your complaint...
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Company: Med-El Elektro-Medizinische Gerate GmbHProduct: Combi C40+ and Pulsar cochlear implant systems Date: 11/16/04 Failure to establish and maintain procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems....
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Company: Clarity Inc.Product: Otologic implants Date: 11/12/04 Failure to document software validation activities for computers or automated data processing systems used as part of production, as required by 21 CFR 820.70(i). Specifically, there is no documentation indicating the automated _____ lathes and mills used to manufacture device implants, have been validated. FDA District: New Orleans...
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Company: Computerized Radiation Scanners Inc.Product: radiation beam scanners Date: 10/19/04 Each manufacturer shall establish procedures for quality audits and conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. Your firm failed...
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Company: Dale Dental Inc.Product: Dental porcelain powder Date: 10/14/04 Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained and that calibration records are maintained [21 CFR 820.72(a) and (b)(2)] [FDA483 Item 5]. For example, your firm has no procedures for performing calibration of the _____ electronic scale...
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Company: Tecan USProduct: Tecan Clinical Workstation and Tecan Genesis RSP Date: 10/8/04 Failure to have complete validation of the _____ software program, as required by 21 CFR 820.30(g). Your firm did not have documentation of complete requirements specifications and software design specification for the entire _____ software program. Documentation of the software program provided by...
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Company: Sterex International Ltd..Product: Epilator high frequency needles Date: 10/8/04 Manufacturing equipment, including _____ needle production machines, packaging equipment, and a computerized visual inspection system have not been validated. FDA District: Center for Devices and Radiological Health (CDRH)
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Company: 3TP LLC.Product: 3TP software Date: 10/5/04 The Diagnostic Devices Branch (DDB), Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your Internet website for 3TP Software. Based on our review of your website, it appears that your company is marketing 3TP Software for intended uses...
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Company: Laser Therapeutics Inc..Product:”MediCom a.s. Low Level Laser” Date: 10/4/04 With respect to protocol [_____] submitted to the _____ under study number _____ and protocol [_____] submitted twice to the _____ under numbers _____ and [_____ some of your electronic records were lost due to destruction by a computer virus and there is no documentation...
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Company: WNCK Inc.Product: BreathScan Detector Date: 9/30/04 Failure to establish and maintain procedures for implementing corrective and preventive action [21 CFR 820.100(a)] [FDA-483 Item 7]. For example, your firm maintained electronic communication records with distributors or customers, but there were no records showing your firm’s evaluation of or action taken on quality issues. FDA District:...
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Company:Daavlin Distribution Co.Product:”3 Series Full-body Phototherapy Device” and other phototherapy units Date: 9/22/04 Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR. 820.30(i). For example, design changes made to the 3 Series Full Body Phototherapy...
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Company:Guardian Drug Co. Inc.Product:Infant Gas Relief Drops, Nausea Contorl Cherry Liquid, Gastro Bismuth Liquid and other drugs Date: 9/15/04 Regarding Observation 15, your response indicates that the computer software was initially validated in April 2001 and that it was going to be revalidated in May 2004. You also included the validation report of the software...
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Company: The Soule Co. Inc.Product:Rapid Foam and other styrofoam products Date: 9/15/04 Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results and all activities are documented as required by 21 CFR...
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Company:General Medical Co.Product: “Drionic Long-term Antiperspirant for Hands & Feet,” “Drionic Long-term Antiperspirant for Underarm Treatment” and “Drionic Special Applications Device for Amputee, Groin and Buttocks” Date: 9/8/04 Your firm failed to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these...
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Company:Roche Diagnostic Corp..Product:Tecan Clinical Workstations, Online TDM Phenytoin diagnostic test kit Date: 9/2/04 Failure to implement procedures to ensure that all purchased products and services conform to specified requirements, as required by 21 CFR 820.50(a) and (b). Specifically, you failed to follow your procedure for adding suppliers of hardware and software accessories used in the...
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Company: Anton Bilchik M.D. – John Wayne Cancer InstituteProduct: CancerVax vaccine Date: 8/31/04 A computerized axial tomography (CAT) scan on 7/8/98 shows progression of disease for subject _____ This subject was continued on the study for three additional months. Test Procedure(s) Not Conducted Pre-study Human Leukocyte Antigen test (HLA); 14 day Purified Protein Derivative (PPD)...
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Company: Piedmont Hospital Inc.Product: Blood and blood components Date: 8/3/04 On March 7, 2004, a technician entered compatibility test results for two blood units (_____ #_____) into the blood bank computer system as compatible. However, the actual test results were not obtained from ARC (who performed the compatibility testing) and there were no compatibility test...
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Company:SinTea Biotech S.p.AProduct: “Traumafix system” and other orthopedic devices Date: 8/2/04 Require that validation activities be conducted using production units or their equivalents; or ensure that design validation also includes software validation and risk analysis, where appropriate. (21 CFR 820.30(g)) Issuer: Center for Devices and Radiological Health (CDRH)
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Company: Aap Implantate AGProduct: Orthopedic implants Date: 7/16/04 Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i), Automated Processes. The regulation under 21 CFR 820.70(i) requires that when computers...
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Company: Inceptio Medical Technologies LCProduct: “Punctsure Vascular Access Imaging Procedure Kits” and other ultrasonic vascular imaging systems and sterile accesories Date: 7/14/04 Failure to validate a process for which results cannot be fully verified by subsequent inspection or test, [21 CFR 820.75(a)]. Your sterilization process validation for the Punctsure Vascular Access Imaging Procedure Kits is...
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Company: Efoora Inc. dba Virotek LLCProduct: Lancets and inoculating loops Date: 5/12/04 Your firm failed to validate computer software used as part of the quality system as required by 21 CFR 820.70(i). For example, your firm has no documented validation activities and results for the _____ electronic data management system. Your firm failed to establish...
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Company: Hunterdon Medical CenterProduct: Biologics/Blood Date: 5/3/04 Failure to maintain accurate records which identify unsuitable donors so that products from such individuals will not be distributed, as required by 21 CFR 606.160(e). For example, in June 2003, it was discovered that all donor cards from the year 2000 were inadvertently destroyed. Without the original donor...
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Company: Tri-Med Laboratories IncProduct: “PSE Carbinoxamine DM Syrup,” “Carbodex DM Syrup,” “Ronddamine DM Syrup” and other drugs Date: 4/28/04 Your investigation report for failing Pediahist lot F312 indicates that the batch was formulated superpotent because the manufacturing order sheet was reproduced from another product format on a computer, hence the incorrect amounts of ingredients were...
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Company: Positron CorpProduct: “POSICAM HZ,” “POSICAM HZL,” “mPower PET” and other Positron Emission Tomography diagnostic scanners Date: 4/26/04 The above-referenced service reports indicated that an upgrade was needed. There are no records attached or referenced in these service reports or clear descriptions to explain if the upgrade was due to a hardware design problem, a...
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Company: Surgilight IncProduct: Optivision Laser System Date: 4/20/04 Validation of Borland Compiler is incomplete because software used to control passwords was not addressed (FDA 483, Item #3) Complaint #17 dated December 17, 2001, references software locked up due to possible computer time and/or patient file recreation. Failure not determined Your firm’s design validation failed to...
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Company: Able Laboratories Inc.Product: Lithium, methylphenidate, phentermine and other drugs Date: 4/19/04 The MedWatch forms which you submitted were on FDA form 3500, which is for the voluntary reporting of ADEs by healthcare workers and consumers. As a drug manufacturer, you must be reporting all domestic ADEs on FDA MedWatch form 3500A. Reports of foreign...
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Company: Cordis Corp.Product: “Cypher Sirolimus-Eluting Coronary Stent” Date: 4/1/04 Failure to adequately validate for its intended purpose and according to an established protocol computer software used as part of the production or quality system, and failure to document validation activities and results, as required by 21 CFR 820.70(i). The automated _____ data acquisition system, used...
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Company: Michigan Instruments Inc.Product: Thumper Model 1007 Mechanical CPR System Date: 3/23/04 You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR...
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Company: American Red Cross Transplantation ServicesProduct: Cryopreserved heart valves Date: 3/11/04 The cryopreservation process dated 5/19/95, Computer Rate Controlled Freezer for Cryopreservation of Human Tissue, was not adequate. The validation included determining the maximum tolerance limits of the cryopreservation unit to freeze heart valves at a specified rate but only cryopreservation solution was used, not...
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Company: Health Directions Inc.Product: Health Pax Cranial Electrotherapy Stimulator Device Date: 3/4/04 -“Most recently, the dramatic evidence of the efficacy of CES entails use of computerized EEG’s or topographical brain mapping, validating that CES alters the abnormal electrophysiology associated with drug/alcohol abuse and other organic brain diseases as well as normalizing other dysfunctional brain wave...
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Company: Ocuserv Instruments Inc.Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems Date: 3/2/04 During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names...
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Company: MedRx Inc.Product: “Otowizard” and “Vet Digitizer” Date: 3/1/04 Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic...
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Company: Shanghai Medical Ltd.Product: Active pharmaceutical ingredients Date: 2/10/04 One of the discussion points with management concerned missing data for the analysis of [redacted] and [redacted] by [redacted] There were six entries in the [redacted] logbook that could not be found in the correlating computer files. The investigative team was together during the interaction with...
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Company: Imaging Diagnostic Systems Inc.Product: Investigational device Date: 1/28/04 Monitors also failed to observe that the first enrolled patient’s…was assessed with an earlier software version. Because earlier software versions were not equivalent to later versions used in the study, the data should not have been included in the data analysis. Issuer: Center for Devices and...
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Company: Respironics California Inc.Product: Espirit mechanical ventilator Date: 1/27/04 The design validation activities conducted for the Esprit ventilator software version 3.2 failed to ensure that the device conforms to the defined user/patient needs and intended uses [21 CFR 820.30]. Specifically: There was no documented evidence that any integration and throughput testing of the device was...
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Company: Rocky Mountain Lions Eye BankProduct: Human corneas, sclera and whole eye globes Date: 1/26/04 Paragraph 12 of the Biohazardous Waste Disposal procedure includes the provision that the Quality Assurance (QA) staff will review and verify the documentation of destroyed tissue on the Destruction Log is consistent with the record entry in the chart and...
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Company: James Howe M.D. – University of Vermont College of MedicineProduct: Investigational device Date: 1/16/04 The x-rays and radiology report for patient [redacted] 24-month visit in 2002 were not included in the subject’s file. The patient’s Radiographic Evaluation form you signed on September 27, 2002, shortly after [redacted] 24-month visit was scheduled to take place,...
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Company: Eldon Biologicals A/S.Product: Medical device Date: 12/23/03 Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program. Failure to validate computer software for its intended use according to an...
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Company: IND Diagnostic Inc.Product: Medical device Date: 12/23/03 Failure to establish and maintain procedures to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results as required by 21 CFR 820.72 (a). Issuer: Center for...
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Company: Medron Inc.Product: Various catheters Date: 12/3/03 We are in receipt of your correspondence dated June 6, 2003 in response to the FD-483 issued at the conclusion of the inspection. Your response is inadequate in that all numbered items listed above were not addressed. However, we acknowledge that you have implemented some corrective action with...
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Company: Central Texas Regional Blood and Tissue CenterProduct: Blood products Date: 11/7/03 Specifically, one donor tested Nucleic Acid Test (NAT) HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the Fresh Frozen Plasma (FFP) to be tested from the 4/16/2002 donation and all tests...
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Company: Tri-State Analytical Laboratory LLCProduct: Analyzed drug products Date: 10/22/03 Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab...
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Company: Medi-Stat Inc.Product: Pulse oximeter sensors Date: 10/17/03 The Device Master Record you submitted is inadequate. A Device Master Record is specific for each device and must include or refer to the location of the following information: a.) device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications; b.) production process specifications including...
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Company: Nutra Med Inc.Product: Over-the-counter and prescription drug products Date: 10/2/03 Failure to maintain records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems. [211.68(a)]. For example, equipment qualification was not adequate for the following drug manufacturing equipment: Double Cone Blender (_____ kg.), Fitzpatrick Fitzmill Comminuting Machine, Coating Pans, Kent...
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Company: Consolidated Machine Corp.Product: Steam sterilizers Date: 9/24/03 Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a...
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Company: Con-Cise Lens Co.Product: Rigid gas permeable contact lenses Date: 9/19/03 Failure to perform and document validation of computer software that is used as part of production [21 CFR 820.70(i)]. Specifically, the software used to control the DAC DLL Series 3…has not been validated. We note that seven items on the Form FDA 483 issued...
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Company: Laborde Diagnostics at South CollegeProduct: Mammography facility Date: 9/12/03 The specific deficiency noted above appeared on the MQSA Post Inspection Report, which was given to your facility by the state inspector along with instructions on how to respond to this finding. Your facility responded to this same noncompliance issue in a letter dated September...
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Company: Medsmex.comProduct: “Isotrex Isotretinoina Gel 0.05% Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...
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Company: Medicapharma.comProduct: “Roaccutane Isotretinoin 10 mg tablet” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part. “Accutane must not be used by females who are pregnant…must...
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Company: Today’s BusinessProduct:”Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...
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Company: Medicine-MexicoProduct: “Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...
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Company: Edrugnet.comProduct:”Roaccutane Isotretinoin 10 mg capsules” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...
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Company: Invacare Corp. Product: Power wheelchairs and scooters Date: 8/26/03 With regard to the 80 amp fuse and …wire assembly, the May 15, 2003 and May 20, 2003 responses indicate that an 80 amp current through this assembly is only sustained for a short period of time. Invacare states that a continuous 80 amp current...
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Company: Boston Scientific Corp.Product: Investigational medical device Date: 8/22/03 For example, the …and the …do not describe whether the monitor should verify all case histories and related documentation or only select a representative sample during the visit. If a sample is to be selected, the procedures do not state the size and composition of this...
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Company:Astro Instrumentation LLCProduct: Chemistry analyzers and renal dialysis filter reprocessing system Date: 8/21/03 Your August 4, 2003 response stated that you routinely use electronic copies of the manufacturing procedures and that a lack of a computer at this work station prompted the use of a paper copy. The response states that you have placed a...
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Company: Bioflex Inc..Product: Electrical stimulation devices Date: 8/18/03 Failure to establish procedures to ensure that equipment is routinely calibrated, checked and maintained. [21 CFR 820.72(a)] For example, the…meter used to test the electrodes on the BioShort electronic stimulation garments has not been calibrated and there is no calibration program for this meter. Failure to establish...
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Company: Mercy Medical Center Product: Blood bank facility Date: 07/25/03 Failure to maintain an adequate number of trained and experienced personnel for the processing, compatibility testing, storage, and distribution of blood or blood components. For example, employee…who was responsible for completing validation of the …software, was also responsible for Quality Assurance, supervisory and administrative duties,...
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Company: South Texas Blood and Tissue CenterProduct: Blood facility Date: 7/17/03 Your facility failed to check input to and output from its computer and related systems for accuracy [21 CFR 211.68(b)]. For example, Your facility’s _____ computer system and _____ lacked controls or procedures to prevent improper sample analysis or mix-ups. As explained above (1.a),...
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Company: MagneVu Product: Portable magnetic resonance imaging (MRI) system Date: 07/11/03 Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated....
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Company: ConMed Corp. Product: Hyfrecator 2000 and other electrosurgical devices and accessories Date: 05/08/2003 Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, a software program used to run...
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Company: Antelope Valley Healthcare District Product: Blood and blood components Date: 05/01/2003 Specifically, the procedure “Donor Registration and Medical Interview,” which includes instructions for entering deferral information into the computer system based on disqualifying information provided during the donor screening process, does not provide details concerning the documentation of information (such as exposure dates) so...
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Company: Advanced Radiation Measurements Inc.Product: Radiation beam scanners Date: 3/25/03 Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used...
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Company: Innovative Products Unlimited Inc.Product: Medical Device products including gurneys Date: 3/4/03 No procedures to control labeling activities, as required by 21 CFR 820.120. For example, while you maintain master labels for your gurney models, these master labels lack signatures and dates to document that they have been reviewed and approved, and there are no...
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Company: MAK-SYSTEM S.A. International GroupProduct: Progesa Soundex file module Date: 02/06/2003 All users are not notified of existing problems or fixes until a user encounters the problem. Software corrections are only provided to the user that discovered and reported the problem and not to other users of the computer system/software. For example There were no...
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Company: Merits Health Products Co. Ltd. Product: Powered wheelchairs, electric scooters and oxygen concentrators Date: 02/04/2003 Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example,...
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