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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.