483
Amgen Inc.Amgen Inc. – FDA 483, Nov 30, 2023
Record Details
Amgen Inc. in New Albany, OH, underwent an FDA inspection focusing on assembly, labeling, packaging, and release testing. The inspection revealed a significant observation where the firm failed to retain sufficient reserve samples of drug product to perform all required release tests for products like Repatha and Enbrel. This indicates a deficiency in quality control and adherence to sampling procedures.
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ID · 75aa020e-b437-4dc6-91e7-56e5dcb4f8f4
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