Mr. Werner M. Hiller
Co-Owner
Getsch+Hiller Medizintechnik GmbH
Sattlerstraße 20 Tuttlingen
78532 Nendingen
Germany
werner.hiller@getsch-hiller.deFEI 3008911114Issued Dec 27, 2022Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008911114.
Violations4
Issue DateDec 27, 2022
Product TypeMedical Devices
StatusClosed
Closeout LetterSep 29, 2023
Letter Details
Firm
Getsch+Hiller Medizintechnik GmbH
Location
Mr. Werner M. Hiller
Co-Owner
Getsch+Hiller Medizintechnik GmbH
Sattlerstraße 20 Tuttlingen
78532 Nendingen
Germany
werner.hiller@getsch-hiller.de
FEI Number
3008911114
Country
Germany
Issue Date
December 27, 2022
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Closed
Closeout Letter
September 29, 2023
Summary
Getsch+Hiller Medizintechnik GmbH, a German manufacturer of monopolar laparoscopic instruments with disposable and reusable tips, failed to comply with FDA's Quality System Regulation (21 CFR Part 820) for medical device manufacturing. The inspection conducted in July 2022 identified that the company did not establish or maintain a Design History File (DHF) for its Class II monopolar laparoscopic instruments intended for the US market, which is required under 21 CFR 820.30(j). The FDA determined the devices were adulterated due to non-conformity with current good manufacturing practices, and found the company's August 2022 response to inspectional observations to be inadequate.
Getsch+Hiller Medizintechnik GmbH FDA Warning Letter, December 27, 2022
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