Amgen, Inc.December 13, 2019

FDA 483 - Amgen, Inc. - December 13, 2019

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Record Details

During an inspection from December 9-13, 2019, the FDA observed deficiencies at Amgen, Inc. in Thousand Oaks, CA. The inspection revealed issues with equipment cleaning and maintenance procedures, specifically regarding the lack of demonstrated disinfection efficacy after microbiological excursions in controlled areas. This indicates a moderate concern regarding the firm's environmental monitoring and control practices.

Company: Amgen, Inc.
Inspection Date: December 13, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Roger F. Zabinski (Investigator)

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ID · 38972f72-b21d-41b2-bb8b-25e715f425e9