Inspections, Compliance, Enforcement, and Criminal Investigations
Tumed Surgical Instruments & Hospital Supplies GmbH 09-Sep-04
Department of Health and Human Services
Public Health Service
2098 Gaither Road
SEP -9 2004
Mr. Dietmar W. Schaupp
Tumed Surgical Instruments & Hospital
Dear Mr. Schaupp:
During an inspection of your firm located in Tuttlingen, Germany on April 13 - 14, 2004, our investigators determined that your firm is a specification developer and labeler for Class I and Class II devices, including electrosurgical cutting and coagulation 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 are 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 analyze 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, as required by 21 CFR 820.100(a)(1). For example, your firm analyzes [redacted]. You received 144 complaints that represented 519 devices. [redacted]
2. Failure to establish and maintain adequate procedures for investigating the cause of nonconformities relating to the product, processes; and the quality system, as required by 21 CFR 820.100(a)(2). For example, your failure investigation procedure was inadequate in its description of how an investigation is to be accomplished.
This inspection also revealed that these devices are misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)] in that your firm failed or refused to furnish material or information required by or under section 519 respecting the device and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Specifically you failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
This letter is not intended to be an all-inclusive list of deficiencies 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 underlying problems in your firm's quality system. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
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. 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 A, General Surgery Devices Branch, 2098 Gaither Road, Rockville, Maryland 20850 USA, to the attention of
Wayne Q. Miller.
If you need help in understanding the contents of this letter, please contact Mr. Miller at the above address or at (301) 594-4618, extension 122 or FAX (301) 594-4636.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and