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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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MAK-SYSTEM S.A. International Group 06-Feb-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Center for Biologics Evalaution and Research
1401 Rockville Pike
Rockville, MD 20852-1448


February 6, 2003

WARNING LETTER
CERTIFIED MAIL - RETURN RECEIPT REQUESTED

Simon Kiskovski
President and CEO
MAK-SYSTEM S.A. International Group
Z1 Paris Nord II
13, rue de la perdrix
BP 50035
95946 Roissy CDG Cedex France

Dear Mr. Kiskovski,

The Food and Drug Administration (FDA) conducted an inspection of MAK-SYSTEM S.A. International Group (MAK), Roissy CDG Cedex, France, from October 7 through 16, 2002. During the inspection, the FDA investigator found evidence that your medical devices are adulterated under Section 501 (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in that they arc not manufactured in conformity with the Current good manufacturing practice requirements of Subchapter H, Part 820, Title 21, Code of Federal Regulations (21 CFR) as follows:

1. Failure to establish and maintain procedures for ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems [21 CFR 820.100(a)(6)], in that:

a. All users are not notified of existing problems or fixes until a user encounters the problem. Software connections arc only provided to the user that discovered and reported the problem and not to other users of the computer system/software. For example:

i. In March 2002, a user reported a problem with Progesa?s Soundex file module which involved an error in the creation and identification of duplicate records after a change or correction in a donor name or date of birth. The user was provided with a fix for the problem in April 2002, however, the fix had been available since December 2000 after the problem had already been reported by another user.

ii. In December 2001, a tier reported a problem concerning the loss of a product modifier when a blood component was returned to the blood bank after it had been distributed. The user was provided a fix for the problem on October 9, 2002. However, a fix for the problem had been available since May 2002.

b. There wore no established procedures for the control and distribution of software fixes to assure that all revised programs required for a particular fix were included and installed on a customer?s system, in thaw a customer reported a problem concerning a product transformation error due to a missing software routine.

2. 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, in that SOP 11901-8, Instruction for Trac_Err File, dated September 2002, did not address the frequency of the receipt and the timeframe for review of customers trace error files. Trace error files document system/database errors that have occurred while using the Progesa software. [21 CFR 820.100(a)(1)]

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, in that types of customer requests were not appropriately categorized, as required in standard operating procedure (SOP) 11901.3, Maintenance Department Internal Instruction, in the [redacted] database, which is used to track the receipt and resolution of software problems, software installation, and inquiries. Numerous reports that should have been categorized as "anomalies" or "bugs" were inappropriately noted as ?miscellaneous". There are ---types of reports noted in the SOP: [redacted]. During the inspection, the FDA investigator reviewed 100 reports from one customer that were categorized and entered into the [redacted] database as "miscellaneous" type. Of the 100 reports reviewed, 29 reports were identified as being incorrectly categorized (26 reports should have been categorized as anomalies and 3 reports should have been categorized as bugs). [21 CFR 820.198(a)]

4. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, in that the test data used to reproduce a problem in the separation program, [redacted] did not match the reported problem or the narrative description in the test documentation. The reported problem concerned the loss of information for labeled blood components when performing a modification of an unlabeled blood component. However, the test documentation for reproducing the problem stated "when modification of volume is performed on one label component, all others lost their order number in [redacted]." The print-screen supporting the purposed fix disclosed that the unlabeled component lost the order number. [21 CFR 820.198(c)]

5. Failure to verify and validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, in that there was no assurance that validation of the corrective action for problem report 20010309/015, which documented a problem concerning the loss of the autologous label designation following a blood unit modification, was effective. The software correction was provided to the reporting user in April 2001. The corrective action was incomplete since it only addressed three of the four possible codes for field 7 in the [redacted] table, and resulted in the removal of the reserved flag in field 18 of the [redacted] table, [21 CFR 820.100(a)(4)]

The above violations are not intended to be an all-inclusive list of deficiencies at your establishment. It is your responsibility, as management, to ensure that your establishment is in compliance with all requirements of the federal regulations.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Federal agencies are advised of the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You should notify this Office in writing, within 15 working days of receipt of this letter, of additional or specific steps you have taken to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will bc completed. Your reply should be sent to the Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, Suite 200N, 1401 Rockville Pike, Rockville, Maryland 20852-1448, Attention: Division of Cast Management, HFM-6 10.

Sincerely,

/s/

Steven A. Masiello

Director

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research