# FDA 483 - Amgen, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/amgen-inc/a1384fcb-8ceb-4fff-b827-7aedea6283ba

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

---

## Details

- Record Type: 483
- Company Name: Amgen, Inc.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Amgen Inc.'s analytical laboratory in Thousand Oaks, CA, revealed deficiencies in method validation studies. Specifically, the firm failed to evaluate all recommended validation parameters, including demonstrating drug stability and method specificity. Additionally, the (b) (4) used in certain studies were not representative of those observed during subject sample analysis.

## Related Documents

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

## Related Officers

- [Stanley Au](https://www.keypedia.com/people/stanley-au/c2931b74-1ffc-40b9-af28-7b9575eb2e26)
- [issuing_officer](https://www.keypedia.com/people/mohsen-rajabiabhari/cb1b2138-7b4f-4e5a-b87f-9b319b14ee81)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321