GE 9-April-99 Solar Model 7000/8000 Patient MonitorsJohn Welch, Jr. Chief Executive Officer General Electric Company 3135 Easton Turnpike Fairfield, Connecticut 06431 Dear Mr. Welch: We are writing to you because on March 8-12, 1999, investigators from the Food and Drug Administration (FDA) collected information from your Marquette Medical Systems, Milwaukee, WI, facility that revealed a...Read More

The Center for Devices and Radiological Health (CDRH), Office of Compliance, Division of Enforcement I, Diagnostic Devices Branch has reviewed the January/February 1999 Establishment Inspection Report of your firm, and the Form FDA 483 dated February 5, 1991, that was issued to you at the close of the FDA inspection. They also reviewed your product...Read More

Radionics 22-March-99 Xknife Stereotactic Radiosurgery System 1. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, that appropriate representatives are included, and that the results of a design review, including identification of the design, the date,...Read More

Abbott 17-March-99 In vitro diagnostic products 2. Failure to document all activities required by 21 CFR 820.100(b) as they relate to corrective and preventive action. For example: a. There is no documentation of the management review and approval of the decision not to send a customer communication to alert Axsym instrument users of a system...Read More

Baxter 3/12/99 Catheters 2. Failure to validate production processes with a high degree of assurance where the results of a process cannot be fully verified by subsequent inspection and test [21CFR 820.75). Specifically, your firm does not have sufficient documented evidence, that the Pulmonary Artery Catheter balloon forming, and the polyethylene (PVC)compounding processes meet their...Read More

In response to your inquiry concerning the need to maintain manual discard records when the same date is computerized, I can assure you that duplicative, manual records are not required, PROVIDED your computer system(s) are validated to ensure that all necessary data is entered, that the stored data is safely backed-up in the event of...Read More

Medical Equipment Designs 9-March-99 Diathermy devices Since 1990, you also modified the design of the Meditherm by introducing software to control the device. Major changes in the intended use of the Meditherm and design changes which could significantly affect safety or effectiveness, such as the introduction of software, require a new premarket notification (510(k)) submission...Read More

Urometrics 9-March-99 Penile tumescence monitors 1. Failure to establish and maintain procedures for the identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i) in that there is no data to show that the NEVA program version 2.2.1 (revised 1/20/99) was validated or verified....Read More

Chronimed 3/2/99 Glucose test strips and meters 5. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b). For example, there is no plan for the software validation for Version 104. 6. Failure to ensure that the design input...Read More

Compex S.A. 2/22/99 Muscle and nerve stimulation devices 2. 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, your firm failed to validate the software...Read More

Inadequate process validation; failure to validate the test methods used to analyze raw materials and the finished product; failure to institute process qualification for the laboratory instruments used to perform in-process and finished product testing; failure to qualify or validate the firm’s computer software programs; and failure to perform investigations into out-of-specification weight and diameter...Read More

Diehl Inc. Food Processing 2/12/99 The chart recorder and the computer display on the xxxx units did not correspond to the mercury-in-glass (MIG) thermometer. The chart recorder or computer display may show a reading up to 3 degrees F higher than the MIG thermometer. SoftwareCPR keywords: Production software, validation, electronic recordsRead More

Knoll Pharmaceutical 12/14/98 Your firm’s equipment qualifications for the Amsco SG-116 autoclave and the computer control system for the 60″ film coating pan were inadequate. SoftwareCPR keywords: software validation, CDER, Drugs, PharmaRead More

Soft Computer Consultants 12/4/98 Blood Bank Computer SoftwareDESIGN CONTROLS 1) Failure to establish and maintain plans that describe or reference the design and development activities, and define responsibility for implementation including the plans that describe the interfaces with different groups that provide input to the design and development process [21 CFR 820.30(b)]. 2) Failure to...Read More

Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers 6. Failure to have an established protocol to validate computer software for its intended use 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, there is no validation protocol for the validation study...Read More

North American Science Assoc 11/24/98 Contract Testing Laboratory Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to...Read More

North American Science Contract Test Laboratory 11/24/98 Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to the...Read More

Allergy Laboratories 8/14/98 8. There are no controls for computer generated labeling used for product inserts. It was noted during the inspection that finished HealthTest HIV 1 + 2 and HBsAg test kits were relabeled from “For in vitro use only” to “For Research Use Only”. SoftwareCPR keywords: software validation, CDRH, devicesRead More

Villa Sistemi Medicali, S.p.A. 9/30/98 Dental x-ray systems Failure to maintain Device Master Records (DMR) that includes or refers to the location of: device specifications including component specifications, software specifications; production process specifications; quality assurance procedures; and labeling specifications as required by 21 CFR 820.181(a)(b)(c) and (d). For example, the firm has no Device Master...Read More

ICS Medical 10/29/98 Diagnostic opthalmic devices 1. Failure to develop, monitor, and control the software development processes to ensure that the software used in _____ conforms to its original design or any approved changes. 2. Failure to review the software development process to identify actions needed to prevent the recurrence of software nonconformances. 3. Failure...Read More

Review of the _____ which consisted of the software and hardware components necessary to _____ DHRs and maintain them as electronic records, revealed the following:. Changes to processes were not always reviewed and evaluated or revalidated, where appropriate, and documented [21 CFR 820.75(c)], in that the software validation dated _____ was completed for software _____...Read More

Bernafon-MAICO Inc. 5/06/97 “Computer Validation The inspection found that the xxxx Computer System, used to add bulk quantities of solvents to the manufacturing processes (from a tank farm) for Ticlopidine and Bromocryptine Mesylate drug substances has not been validated (FDA-483 Item #16). The response to FDA-483 Item #16 is inadequate. Your firm’s commitment is to...Read More

Failure to validate and document significant manufacturing processes and quality assurance tests to assure specific requirements are met, e.g., robot and manual welding processes, and software used to program the chip in the control device of the automatic air mattress. Your firm’s response dated July 30, 1998 and signed by Edward A. Kroll, Director, TQM...Read More

Sabratek Corp. 8/19/98 Infusion pumps 1. Failure to identify the actions needed to correct and prevent recurrence of non-conforming product. For example, it was determined that the _____ had a software problem which prevented the infusion rate from exceeding the bolus rate while operating in the “PCA” mode. While the software has been revised, the...Read More

Allergy Laboratories 8/14/98 4. Failure to routinely calibrate, inspect, or check for accuracy and to exercise appropriate controls for automatic, mechanical, or electronic equipment or other types of equipment, including computers, used in the manufacture, processing, packaging, and holding of a drug product according to a written program designed so as to assure performance [21...Read More

Imaging Sciences International Inc. 7/21/98 CommCat IS-2000 Imaging System dental tomographic and panoramic X-ray machine c) Repair requests beyond the one-year warranty period are not reviewed to determine whether they are complaints, nor is information obtained by the software phone service documented and reviewed for potential complaints.Read More

Multidata Systems Intl. Corp. 7/16/98 Decision Support Systems (DSS) for Radiation Support device 1. Failure of management with executive responsibility to appoint a member of management to establish authority over and responsibility for (a) ensuring that quality system requirements are effectively established and effectively maintained, and (b) reporting on the performance of the quality system...Read More

Failure to investigate adverse device effects;failure to install password clearance on computer You failed to investigate the failure of the _____ when operating in MS Access. The system locks up at random and it is unknown whether the software which controls the _____ during _____ which operates off of MS Excel, could be similarly affected....Read More

Hil-rom 6/25/98 Isolette C2000 Infant Incubators Failure to assure that all inspection and testing equipment is suitable for its intended purposes and is capable of producing valid results. The inspection revealed that the _____ automated simulator test has not been updated to keep current with hardware and software changes made to the C2000 device. (FDA...Read More

m. concerning the _____ software, used for the handling, storage, and distribution of product…Your response states that the _____ software will be validated. Please note that the establishment of an adequate validation protocol, including system specifications and criteria for demonstrating that the software will meet the requirements, is necessary in order to conduct adequate validation.Read More

.Select Brand Antacid Peppermint Tablets, 75’s, Lot #7026, manufactured on March 1997, was placed “On Hold”, but was not physically labeled as such, nor did the computerized inventory system indicate this status. Accucal Calcium Antacid Peppermint Tablets, 150’s, Lot #7075 was marked “Rejected” as stored in the warehouse, but this status was not indicated in...Read More

7. You have failed to establish appropriate procedures to assure that computerized processing control systems and data storage systems used in the production and quality systems at Ansell, Inc. are secured and managed to assure the integrity of processes and data that could effect the conformance of the condoms to established specifications. Examples of such...Read More

Lumisys 5/12/98 MammoWorks” an interactive database designed for mammography practices and teleradiology devices. 1. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications [21 CFR 820.70]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that your production process...Read More

DeRoyal Cientifca Esophageal Stethoscopes 5/1/98 “1. 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). This would also be a violation of the GMP Regulation, 21 CFR...Read More

Failure to establish adequate written-recall procedures and to validate the computer software programs designed to facilitate recall of distributed drug products.Read More

/Docs/cernerWL.pdfRead More

Bioresearch 3/31/98 TMJ diagnosois software Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that...Read More

Hitachi 3/30/98 In vitro diagnostic analyzers 1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) (4). This would be a violation of the 1978 Good Manufacturing Practices Regulation, 21 CFR 820.162, inadequate failure investigation. For example, software release versions were not documented as required or...Read More

.Controls on your laboratory computer system software _____ allow saved chromatograms to be re-integrated without designation as a saved file. The saved chromatograms that are re-integrated then cannot be restored as original data. SoftwareCPR Keywords: Part 11Read More

… Failure to ensure that automatic, mechanical, and electronic equipment, including computer(s) are inspected or checked according to a written program designed to assure proper performance [21 CFR 211.68]. For example, your computer software used for tracking raw material, finished product quarantine/release, and archiving master formulas has not been validated…. SoftwareCPR Keywords: Drug, PharmaRead More

Scottcare 2/25/98 TeleRehab II Cardiopulmonary Monitoring System Failure to maintain a complete Device History Record (DHR) in that it does not contain updates to software or their location, or document rework and evaluation of non-conforming finished devices or part.Read More

Nikkiso Co. Ltd. 1/27/98 Hemodialyzers 2. Failure to validate computer software for its intended use according to an established protocol when software is used as part of production or the quality system, as required by 21 CFR 820.75(j). For example, the software used to perform _____ has not been validated. This software is part of...Read More

Witt Biomedical Corp. 1/23/98 Cardiac catherization monitoring system Failure to establish and maintain adequate procedures for changes to a specification, method, process, or procedure, e.g., software installation procedures are being changed without using an approved process pursuant to established procedures;Read More

Mennen Medical Ltd. 1/21/98 Patient Monitors c. The approval page for the Horizon 9000WS Cathlab’s software located in the document control department contained the signature of the originator of the document, but it lacked an approval signature. This approval page was different from the approval page for the same software located in the production department....Read More

Failure to document approval of all documents established to meet the requirements of part 820, including the date and signature of the individual(s) approving the document, as required by 21 CFR 820.40(a). For example, the device master record was not signed or dated to indicate approval, and the master and working copies of Software for...Read More

No evidence of validation of computer system or software; use of unrecognized testing methods for testing and release of finished products; and no review and approval by the Quality Control Unit of Oxygen USP and Nitrogen NF. 1. No documented evidence of the validation for the computer system or associated software that is responsible for...Read More

Failure to validate the finished device testing software for the ProNeb and Duraneb 2000 compressors and complaint handling software according to established protocols; failure to establish written procedures for monitoring and control of process parameters; failure to establish written procedures and to develop specifications for the contract manufacturer; and failure to establish final acceptance procedures....Read More

b. Changes made to the software program for the _____ have not been formally reviewed and approved by designated representatives of the firm…..Your response is not adequate because it does not include documentation showing formal review and approval of the software program changes. a. A user manual (or SOP) is not available for the _____...Read More

3) There are insufficient controls in place to ensure the integrity of calculated data generated by the _____ software in the Quality Control Laboratory, in that:.Read More

Failure to review, evaluate and investigate complaints involving the possible failure of a device to meet any of its performance specifications; failure to thoroughly evaluate and investigate complaints; and failure to validate software used in tracking and trending service and complaints. 4. Failure to validate software used in tracking and trending service and complaints. For...Read More