483
Fresenius Medical Care, North AmericaFresenius Medical Care, North America – FDA 483, Aug 13, 2020
Record Details
Fresenius Medical Care, North America in Ogden, UT, a sterile drug manufacturer, was cited for two observations during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies related to rejected batches and lacked adequate written procedures for production and process controls. These deficiencies included issues with retaining critical alarm logs and controlling certificates of analysis.
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ID · f722a98a-9b92-40b1-8c0a-5c07ebf6c6a6
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