Amgen Inc.November 30, 2023

FDA 483 - Amgen Inc. - November 30, 2023

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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.

Company: Amgen Inc.
Inspection Date: November 30, 2023
Product Type: Drugs
Office: Cincinnati District Office
People: Andrew J. Barrowcliff
Geoffrey K. Kilili (investigator)

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ID · 75aa020e-b437-4dc6-91e7-56e5dcb4f8f4