# FDA 483 - Amgen, Inc. - May 16, 2017

Source: https://www.globalkeysolutions.net/records/483/amgen-inc/a23066f5-45d7-4383-9490-ac82f211990c

> FDA 483 for Amgen, Inc. on May 16, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Inspection Date: 2017-05-16
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Amgen Inc. in Thousand Oaks, CA, received a Form 483 with five observations related to deficiencies in drug substance manufacturing. The observations highlight issues with cross-contamination prevention, cleaning validation, product hold times, validation processes, and procedural controls. These findings indicate a need for improved quality system oversight to ensure consistent and compliant operations.

## 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

- [issuing_officer](https://www.globalkeysolutions.net/people/jee-y-chung/0736677f-9719-44dc-9dab-60b610ac1a0a)
- [investigator](https://www.globalkeysolutions.net/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)
- [Sarah Arden](https://www.globalkeysolutions.net/people/sarah-arden/bf00f354-fe31-4c0d-8d2c-a0447b388e2d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0