483Company: Eli Lilly & Company City and Sate: Indianapolis, IN FDA District: Detroit, MI Dates of Inspection: 1/29-2/9, 21, 22, 23/01 18. SOP #001-001757 “Process Control System Security” is used as a global document to describe the guidelines for maintaining the security of the process control systems and related documents for Parentaeral Products Operations. However,...Read More

The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...Read More

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Company: DPC Cirrus, Inc., Date of Enforcement report: 2/7/01 Date of recall: 11/3/00 Class: III PRODUCT: Immulite 2000 Automated Immunoassay Analyzer Software Versions 1.6 and 1.61. Recall No. Z-183-1. REASON: Software code is incorrect for manual dilutions in the Batch Tests by Rack, which could cause incorrect calculation of results. CODE: None. MANUFACTURER: DPC Cirrus,...Read More

Company: Raichem Date of enforcement report: 1/31/01 Date of recall: 12/20/00 PRODUCT: Roche Creatinine Mira, Catalog No.3033414. Recall #Z-071-1. REASON: Package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735. CODE: Lot No. A12071, Exp. September 2002. MANUFACTURER: Raichem, division of Hemagen, San Diego,...Read More

Date of Recall 4/4/00 Date of Enforcement Report: 01/24/01 PRODUCT: LTV Series Ventilator. Recall Nos. Z-154/156-1. REASON: Failure of the LTV series ventilator software to detect a disconnect. CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900. MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA. RECALLED BY: Manufacturer, by letter on April 4,...Read More

Company: Aventis Behring L.L.C.Date: 1/22/01 Product: Biological products Product category: Human Drugs Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry...Read More

Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...Read More

In 2000, a coalition of trade associations was formed to provide input to FDA regarding interpretation of Part 11. This unusual effort across industries has been undertaken due to the global nature of the rule and the cost and impact of compliance to the rule depending on interpretation. The initial group of six national trade...Read More

Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the yyyy System and zzzz network computer software programs for materials and data management functions. The —- performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...Read More

Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the _____ System and _____ network computer software programs for materials and data management functions. The _____ performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...Read More

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Earlier this month FDA recognized UL 1998 for software. It followed up in the second half of the month by publishing new supplmentary information sheets for all recognized software standards that explains the recognition and how each could be used to reduce software documentation in submissions. Subscribers to SoftwareCPR.com can login, go to the Library...Read More

PRODUCTFastTake Compact Blood Glucose Monitoring System, used to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use, under the following trade names: One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S. and Canada); PocketScan Compact Blood Glucose Monitoring System (in the United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in...Read More

Societa Italiana Mediciniali Scandicci 12/6/00 APIs …The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete…. We have also reviewed your November 3, 2000 written response to the FDA-483…...Read More

PRODUCT Escort E300 Series Patient Monitor, intended use is as an electrocardiograph and respiration monitor. Recall #Z-030-1. REASON It is possible for the High Breath Rate Alarm to function incorrectly under certain conditions. CODE Serial numbers are non-sequential (there are gaps), are four digits long and include: 1001 to 4086. MANUFACTURER Medical Data Electronics, Arleta,...Read More

SOL Pharmaceuticals – Active pharmaceutical ingredients – Human Drugs For example, values in at least two … areas were altered. Altered values were written under computer generated values on the … and used in the potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to DMF Your...Read More

As of 11/15/00 FDA CDRH formally recognizes “ANSI/UL 1998 Software in Programmable Components” for software submissions. Details of the recognition have not yet been posted by FDA as of 11/19/00 but the original intent was for this to be the first software standard to be recognized for devices with software of a MAJOR level of...Read More

The _____ systems calibrated by an outside contractor did not include verification of the precision (% RSD) of the autoinjector at more than one injection volume, the flow rate below 1 ml/min, or the wavelength accuracy for the wavelength regions used for testing of _____. In addition, the _____ software programs had not been verified...Read More

The Good Automated Manufacturing Practice (GAMP) organization issued a final draft for review of a guidance for achieving Part 11 compliance for Electronic Records;Electronic Signatures. It is available at the link provided or go to www.gamp.org for more information.. GAMP Part11 draft Note: this is not an FDA Guidance. It was written by an industry...Read More

“Your firm failed to adequately validate software integral to the IVD, IVD wireless and … devices as required by 21 CFR 820.75. For example, structural testing of the software is not completed or documented, there are no software validation protocols available, and the compilers were not validated (FDA 483, Item #5).” SoftwareCPR keywords: Product software,...Read More

Class: IIPRODUCT Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A- 401. Recall #B-860-0. REASON The Autopheresis-C Plasmapheresis instruments with version 6.0 software may proceed to “Saline Rinse” without displaying the Remove Plasma prompt. CODE Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585 MANUFACTURER Baxter Healthcare Corporation, Largo, Florida. SOFTWARE DEVELOPER Baxter Healthcare Corporation, Round Lake,...Read More

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Oak Rubber Inc. 9/14/00 Examination gloves A failure to validate the manufacturing process and the computer system used to maintain the product inventory and shipping information. FDA New Orleans District SoftwareCPR Keywords: production softwareRead More

Crystal Medical Technology 9/14/00 Dental Implant Devices The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and...Read More

Failure to maintain accurate, complete, and current records of device accountability [21 CFR 812.140(b)(2)]. There is no documentation of the number of_____ and _____ manufactured and distributed, the number of copies of the controlling software made, or the disposition of each copy of the software. There are no records showing to which sites the device...Read More

Company: Baxter Healthcare Corp. Date: 8/11/00 Product: Drug Products Failure to conducted and/or document input/output checks of the _____ computer system. [21CFR211.68] In addition, we further request details regarding steps your firm is taking to bring your electronic cGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures. Part...Read More

21 CFR 820.184 (d), requires the Device History Record (DHR) to contain or refer to the location of records that demonstrate that the device is manufactured in accordance with the Device Master Record (DMR). Our investigator noted that the wavelength spectrum printout at 200 mWatts (mW) of laser power was not kept nor filed in...Read More

We are writing to you because we have obtained information that has revealed a serious regulatory problem involving a product known as “Dermal Tone,” which is marketed by your firm. The Dermal Tone is promoted and sold on the Internet at www.dermaltone.corn. See enclosed website material dated 6/29/00. This website material states that “The Dermal...Read More

Failure to have appropriate controls over computer or related systems to assure that changes in records are instituted only by authorized personnel, as required by 21 CFR 211.68(b). For example, see FDA-483 observation 12.Read More

PRODUCTComponents and Distribution Information System (CDIS) Stand Alone Blood Bank Software. Recall #B-1094-0. REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation. CODE All versions up to and including version 1.1.1. MANUFACTURER Information Data Management, Inc., Rosemont,...Read More

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The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at DManalan@softwarecpr.com or 978-266-1220. BOSCON manalan QSITRead More

Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under...Read More

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Failure to develop, conduct, control and monitor production processes; failure to review the associated data and documentation for finished devices prior to release; failure to validate processes adequately; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate computer software adequately; and five other violations. Failure to validate computer software...Read More

The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry...Read More

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You failed to evaluate suppliers of components and other materials used to assemble the WatchChildTM device. You had not documented your decisions to use the approved vendors on the approved vendor list. While you have a written procedure for supplier certification and recertification, it was not being followed. The type and extent of control to...Read More

6. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of Part 820 as required by 21 CFR 820.40(a). For example: a) There is no requirement for documenting the signature of the individual approving the document. In your firm’s letter of April 6,...Read More

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Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70( i). For example, the firm did not validate software for electronic records and electronic signatures. Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic...Read More

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.Failure to maintain device master records (DMR’s) for each type of device including or referring to the location of device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a) . For example:.Read More

You have also failed to establish written procedures for all operations being performed by your blood bank. No written procedures are established for registering donors electronically, registering donors manually on your mobile unit, maintaining your donor base and searching for duplicate and/or unsuitable donors on a set schedule, review of donor suitability records to assure...Read More

PRODUCT Version 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device. Recall #Z-774-0. REASON Due to a software defect, there could be...Read More