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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Normed Medizin-Technik GmbH 18-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Devices and Radiological Health
2098 Gaither Road
Rockville, MD 20850


NOV 18, 2005

WARNING LETTER

VIA FEDERAL EXPRESS

Ronald Worner
President
Normed Medizin-Technik, GmbH
UlrichstraBe 7 - D-78532 Tuttlingen
Germany, Republic of

Dear Mr. Worner:

During an inspection of your firm located in Tuttlingen, Germany on July 11, 2005, through July 14, 2005, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures various distraction and titanium bone plates, as well as surgical devices. These products are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).

This inspection revealed that these devices appear to be adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Significant violations include, but are not limited to, the following:

1. Failure to validate with a high degree of assurance and approve according to established procedures, where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 320.75(a). For example:

a. A steam sterilization study reportedly considered 3 straight foot plates stacked on top of each other in a Teflon surgical set as worst case configuration, but the study reported validating only 2 straight foot plates stacked on top of each other in a tray.

b. Two positive test results recorded by the lab were not confirmed, including enumeration and identification of cfu reported in the steam sterilization validation reports, as required by the firm's procedures.

2. Failure to perform design validation under defined operating conditions and ensure that devices conform to defined user needs and intended uses, as required by 21 CFR 820.30(g). Specifically, the sterilization procedure in the instructions for use was not validated to demonstrate that they conformed to defined user needs and intended uses.

3. Failure to adequately assure that finished devices are not released for distribution until the activities required in the DMR are completed, as required by 21 CFR 820.80(d)(1). Specifically, 13 "Device History Files" (DHF) failed to record one or both cleaning steps and 5 DHF failed to record tolerance testing.

4. Failure to conduct quality audits according to established procedures, as required by 21 CFR 820.22. Specifically, quality audits that were scheduled for June 2004 were not conducted until December 2004 and January 2005, and no evaluation was made for the appropriateness of the change.

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations, and taking prompt actions to permanently correct the violations and to bring your products into compliance.

We received a response from Ronald Worner, President dated August 1, 2005 concerning our investigator's observations noted on the FDA 483. We have reviewed your response and have concluded that it is inadequate for the following reasons:

1. Documentation was provided of your firm's intent to re-validate the sterilization process according to the previously established protocol. Additionally, documentation was provided from the lab stating that the positive results were a typo.

This response is not adequate because re-validation has not yet been performed and verified and there is no information regarding corrective action to be taken related to all products sterilized under a procedure which has not been properly validated. Furthermore, your firm has not identified what action will be taken to ensure that procedures related to obtaining confirmation of positive sterilization validation results are followed in the future or performed any preventive action to ensure that similar problems have not occurred related to other products.

2. No information was provided related to design controls. This response is not adequate because it does not address the proper corrective and preventive actions to be taken with respect to design validation and design review practices and procedures to ensure that design validation is performed adequately prior to approval.

3. Documentation was provided of meetings to discuss the incorrectly completed production pages and possible corrective action, changes to the "Goods Receipt (Implants and Special Products)" procedure as well as the internal auditing plan and training of personnel to the new procedure. This response is not adequate because no evaluation was made regarding the possibility of non-conformances related to manufacturing process done on products that may not have undergone the cleaning process. Additionally, it is not sufficient to rely on subsequent cleaning steps to correct the problem as they are not validated to do so.

4. An audit schedule for 2005 including identification of an external auditor as well as a promise that management will monitor that audits will be performed as scheduled in the future was provided.

This response appears to be adequate, but will need to be verified during the next FDA inspection. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)).

Please notify this office in writing within fifteen (15) working days from the date you receive this letter, of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include all documentation of the corrective action you have taken. If you plan to make any corrections in the future, 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 B, Orthopedic, Physical Medicine, and Anesthesiology Devices Branch, 2098 Gaither Road, Rockville, Maryland 20850 USA, to the attention of William MacFarland.

If you need help in understanding the contents of this letter, please contact William MacFarland at the above address or at (240) 276-0120 or FAX (240) 276-0129.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health