Tag

warningletter

Software Warning Letters

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....
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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)
Read More
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...
Read More
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...
Read More
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:...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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)...
Read More
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...
Read More
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)
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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,...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
1 2 3 4 5 6 9

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.