# Amgen, Inc. – FDA 483

Source: https://www.keypedia.com/records/483/amgen-inc/3fd38f88-0f27-4242-95c6-59ba05cffdc8

> FDA 483 for Amgen, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Product Type: drugs
- Office Name: Division of Inspectional Assessment
- Summary: Amgen Inc. in Thousand Oaks, CA, a drug substance manufacturing facility, was cited for multiple deficiencies related to quality control, risk assessment, and manufacturing processes during an FDA inspection. Key issues included inadequate investigations into cell bank stability failures, deficient raw material quality assessment leading to viral contamination, and insufficient validation and record-keeping practices. These observations indicate a need for improved quality systems to ensure product sterility and integrity.

## Related Documents

- [483 - 2025-03-13](https://www.keypedia.com/records/483/amgen-inc/f158a248-7fa2-44df-9ef9-74b5f972894b) — date: March 13, 2025
- [483 - 2024-02-06](https://www.keypedia.com/records/483/amgen-inc/e9edaa4a-6d46-4674-882b-fc862d99421c) — date: February 6, 2024
- [EIR - 2019-12-13](https://www.keypedia.com/records/eir/amgen-inc/7155ec06-4efb-4490-8b2d-eecd030871d1) — date: December 13, 2019
- [483 - 2019-12-13](https://www.keypedia.com/records/483/amgen-inc/38972f72-b21d-41b2-bb8b-25e715f425e9) — date: December 13, 2019
- [483 - 2017-05-16](https://www.keypedia.com/records/483/amgen-inc/a23066f5-45d7-4383-9490-ac82f211990c) — date: May 16, 2017

## Related Officers

- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)
- [Bo Chi](https://www.keypedia.com/people/bo-chi/0016303e-704f-4a0a-ad1d-6ae4efdc1b19)
- [Daviana Ligons](https://www.keypedia.com/people/daviana-ligons/15f1ae6a-eaa0-4417-8d68-366c9ce36719)
- [Frances Namuswe](https://www.keypedia.com/people/frances-namuswe/d64cc7a2-3840-41c9-ae6c-fe225a651369)

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

Office: https://www.keypedia.com/offices/division-of-inspectional-assessment/9bc7aff2-93a7-404a-8015-0f93c3701c13