# FDA 483 - Amgen Inc. - November 30, 2023

Source: https://www.keypedia.com/records/483/amgen-inc/75aa020e-b437-4dc6-91e7-56e5dcb4f8f4

> FDA 483 for Amgen Inc. on November 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Inc.
- Inspection Date: 2023-11-30
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Amgen Inc. in New Albany, OH, underwent an FDA inspection focusing on assembly, labeling, packaging, and release testing. The inspection revealed a significant observation where the firm failed to retain sufficient reserve samples of drug product to perform all required release tests for products like Repatha and Enbrel. This indicates a deficiency in quality control and adherence to sampling procedures.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/amgen-inc/e45f55dc-b5f8-4f89-bb33-b6908e0cbaa2)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/amgen-inc/4b2c5b28-7150-43ac-be26-8be9d627bc54)

## Related Officers

- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)
- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.keypedia.com/companies/amgen-inc/f15d2d1c-3482-417a-83de-0efa632c4095

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22