483
Amgen, Inc.Amgen, Inc. – FDA 483, Dec 13, 2019
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.
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ID · 38972f72-b21d-41b2-bb8b-25e715f425e9
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