# FDA 483 - Amgen, Inc. - March 13, 2025

Source: https://www.globalkeysolutions.net/records/483/amgen-inc/f158a248-7fa2-44df-9ef9-74b5f972894b

> FDA 483 for Amgen, Inc. on March 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Inspection Date: 2025-03-13
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Amgen, Inc. in Thousand Oaks, CA, was cited for significant deficiencies across its manufacturing and quality control operations. Observations included failures in preventing microbiological contamination during sterile filling, inadequate investigation of discrepancies in visual inspection qualification records, and deficient microbial examination of in-process materials. Additionally, the firm lacked proper systems and training to ensure compliance with DSCSA verification requirements.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/amgen-inc/b96aeb10-a857-41b8-8fa5-8ca2465cce5a)
- [EIR - 2019-12-13](https://www.globalkeysolutions.net/records/eir/amgen-inc/7155ec06-4efb-4490-8b2d-eecd030871d1)
- [483 - 2017-05-16](https://www.globalkeysolutions.net/records/483/amgen-inc/a23066f5-45d7-4383-9490-ac82f211990c)
- [483 - 2019-12-13](https://www.globalkeysolutions.net/records/483/amgen-inc/38972f72-b21d-41b2-bb8b-25e715f425e9)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/amgen-inc/3fd38f88-0f27-4242-95c6-59ba05cffdc8)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/michael-t-cyrus/30e497e1-2c17-4dd7-9a5b-251771cf4266)
- [Development Coordinator](https://www.globalkeysolutions.net/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)
- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

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

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