Inspections, Compliance, Enforcement, and Criminal Investigations
Marquet GmbH & Co KG 03-Mar-04
Department of Health and Human Services
Public Health Service
Center for Devices and
MAR 3 2004
VIA FEDERAL EXPRESS
Maquet GmbH & Co. KG
Kehler Strasse 31
76437 Rastatt Germany
Dear Mr. Ballhaus:
During an inspection of your firm, ALM S.A., located in Orleans Cedex 2, France on November 3, through November 6, 2003, our investigator determined that your firm manufactures ceiling surgical lamps. These products are devices as de fined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant violations include, but are not limited to the following:
1. Failure to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part, and the quality system, as required by 21 CFR 820.20(c). For example, the procedure entitled [redacted] were not followed in that management reviews were not conducted on a [redacted]. Additionally, not every member of the management team was present for the management review.
2. Failure to maintain procedures to ensure that the Device History Records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For examnle, the device manufacturing records entitled [redacted] are not maintained within the DHR and have been discarded. This has been observed in 32 out of 461 records reviewed between March 26, 2001 and October 24, 2003.
3. Failure to document evaluation and investigation of nonconforming product, as required by 21 820.90(a). For example, on November 3, 2003, during a walk through the plant with the investigator, it was observed that [redacted] failed the electronic/software controlled/computerized finished device test bench finished device testing. The failure was attributed to an earth ground continuity test failure. The evaluation was not adequately documented, and there appears to have been no investigation.
4. Failure to document in the DHR rework and reevaluation activities, as required by 21 CFR 820.90(b)(2). For example, rework/reprocessing of [redacted] that fail finish device testing on the software driven test bench is not maintained within the DHR.
5. Failure to document process validation activities and results, as required by 21 CFR 820.75(a). For example, software validation for the finished device testing bench for the [redacted] is not complete.
6. Failure of finished device acceptance procedure to ensure that each production run, lot, or batch of finished devices meet acceptance criteria by an authorized signature of a designated individual, as required by 21 CFR 820.80(d)(3). For example, finished [redacted] are released for commercial distribution without the signature of the individual and without the date authorizing the release of the devices within the DHR. This has been observed in 32 out of 461 records reviewed between March 26, 2001 and October 24, 2003.
7. Failure ofprocedures to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.l00(a)(3). For example, the procedure entitled, [redacted] does not included corrective actions taken for process improvement.
Additionally, your devices are misbranded under section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information required by or under section 519 respecting the device and 21 CFR Part 803 (Medical Device Reporting). You failed to develop, maintain, and implement written MDR procedures for timely, and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements, as required by 21 CFR 803.17(a)(1). For example, the written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting. Specifically, the procedure entitled [redacted] does not include provisions for reviewing safety incidents which occur in France for Medical Device reportability to FDA.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with each requirement of the Act and regulations. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems.
You should take prompt actions to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice, which may include detaining your devices without physical examination upon ent ry into the United States until corrections are completed. Section 801(a) of the Act, 21 U.S.C. § 381(a). In addition, federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when conside ring the award of government contracts.
We received a response from Ms. Laurence Jeronne, Quality Systems Manager, dated December 5, 2003, concerning our investigator's observations noted on the FDA 483. Your response appears on its face to adequately address the, investigator's observations. However, a follow-up inspection is necessary to ensure that the implementation of the proposed corrections is adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection. You will receive notice of FDA's findings, including whether FDA has been able to verify that implementation of your proposed corrections is adequate.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of any additional steps you have taken to correct the noted violations. Include all documentation of the additional corrective action you have taken. If you plan to make any additional corrections, include those plans with your response to this letter as well. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement A, General Surgery Devices Branch, 2098 Gaither Road, Rockville, Maryland 20550 USA, to the attention of Wayne Q. Miller.
If you need help in understanding the contents of this letter, please contact Wayne Q. Miller at the above address or at (301) 594-4618 or FAX (301) 594-4636.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and