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

Source: https://www.keypedia.com/records/483/amgen-inc/38972f72-b21d-41b2-bb8b-25e715f425e9

> FDA 483 for Amgen, Inc. on December 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Inspection Date: 2019-12-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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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## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/amgen-inc/85ec512e-6991-42ee-9cd5-148cfe0ed3e8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6