FDA to Refuse Entry of German Company's Devices for CGMP, MDR Violations
The Food and Drug Administration will refuse entry of a device manufactured by Ulrich GmbH after finding violations of FDA regulations during an inspection of the company’s Ulm facility, the agency said in a warning letter dated Aug. 15. FDA…
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said Ulrich’s Pezo PEEK Cage System doesn’t conform to current good manufacturing practice and medical device reporting requirements. FDA detention without physical examination of the devices will continue until the violations are corrected, the agency said.