# FDA 483 - Amgen, Inc. - February 06, 2024

Source: https://www.keypedia.com/records/483/amgen-inc/e9edaa4a-6d46-4674-882b-fc862d99421c

> FDA 483 for Amgen, Inc. on February 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Inspection Date: 2024-02-06
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Amgen Inc. in Thousand Oaks, CA, was cited for significant deficiencies during an FDA inspection. Observations included poor aseptic processing techniques, inadequate environmental monitoring, and insufficient smoke studies in sterile drug product manufacturing. Additionally, the firm's documentation practices, cross-contamination prevention, electronic data system controls, and quality unit oversight were found to be inadequate.

## Related Documents

- [483 - 2019-12-13](https://www.keypedia.com/records/483/amgen-inc/38972f72-b21d-41b2-bb8b-25e715f425e9)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/amgen-inc/b96aeb10-a857-41b8-8fa5-8ca2465cce5a)
- [483 - 2017-05-16](https://www.keypedia.com/records/483/amgen-inc/a23066f5-45d7-4383-9490-ac82f211990c)
- [EIR - 2019-12-13](https://www.keypedia.com/records/eir/amgen-inc/7155ec06-4efb-4490-8b2d-eecd030871d1)
- [483 - 2025-03-13](https://www.keypedia.com/records/483/amgen-inc/f158a248-7fa2-44df-9ef9-74b5f972894b)

## Related Officers

- [Esther C. Broner](https://www.keypedia.com/people/esther-c-broner/5df7ca72-a21f-4586-a5e0-8a782045281c)
- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/della-shin/8af7ca3c-d2c8-4712-9644-4de0bd4d638f)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b