# FDA 483 - Amgen, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/amgen-inc/0f69de0e-3c79-4e80-8482-84801428e3f1

> 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: An FDA inspection of Amgen Inc.'s drug substance manufacturing facility in Thousand Oaks, CA, revealed two significant observations. The firm's procedural controls and process containment were found inadequate to prevent cross-contamination by a potent biological product, lacking proper risk assessment and cleaning validation. Additionally, equipment was not stored appropriately after cleaning, leading to microbial contamination due to inadequate procedures for post-cleaning handling.

## 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 - 2025-03-13](https://www.globalkeysolutions.net/records/483/amgen-inc/f158a248-7fa2-44df-9ef9-74b5f972894b)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/amgen-inc/3fd38f88-0f27-4242-95c6-59ba05cffdc8)
- [WARNING_LETTER - 2013-06-17](https://www.globalkeysolutions.net/records/warning_letter/amgen-inc/980f4f23-54ec-4bfd-b859-cf7b7d38566c)

## Related Officers

- [Senior Consumer Safety Officer ](https://www.globalkeysolutions.net/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)
- [Jun Park](https://www.globalkeysolutions.net/people/jun-park/bbccdb05-1fdb-4f8c-9cc0-9f789e2eeec0)
- [Joel Welch](https://www.globalkeysolutions.net/people/joel-welch/210c85c7-6faa-400a-b7a2-87129d331093)
- [investigator](https://www.globalkeysolutions.net/people/steven-fong/c3e7e6b4-8ab0-4dcf-b7c7-acadbfbc3fba)
- [Bo Chi](https://www.globalkeysolutions.net/people/bo-chi/9c83477d-58c1-4183-832e-ce8cbd25a521)

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

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