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warningletter

Software Warning Letters

Recipient: National Genetics Institute.Product:HIV-1 and Hepatitis C virus nucleic acid tests Date: 1/17/2006 FDA District:Los Angeles District Office Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written...
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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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