# FDA 483 - Amgen Manufacturing Ltd - May 08, 2019

Source: https://www.keypedia.com/records/483/amgen-manufacturing-ltd/db055c96-2f65-4c7a-9a05-a08a419d05ad

> FDA 483 for Amgen Manufacturing Ltd on May 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2019-05-08
- Product Type: biologics
- Office Name: Division of Advertising & Promotion 
- Summary: Amgen Manufacturing Limited (AML) in Juncos, PR, was inspected and cited for significant issues in its Enbrel drug substance manufacturing. Observations included inadequate contamination controls, insufficient performance qualification, ineffective corrective actions for leaks, and non-conformance with the Biologics License Application. These deficiencies led to bacterial contamination and discontinuation of multiple commercial batches.

## Related Documents

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- [483 - 2019-04-11](https://www.keypedia.com/records/483/amgen-manufacturing-ltd/2151d238-ef8a-48d6-bb0e-e262677fe58d)

## Related Officers

- [investigator](https://www.keypedia.com/people/riley-myers/22266738-1313-45db-902d-eaf4c63d4131)
- [investigator](https://www.keypedia.com/people/ashley-queen/8a53ebd7-95a4-4403-b853-ba0ebf3e973b)
- [Audrey George](https://www.keypedia.com/people/audrey-george/91f6763d-9501-4c38-b82b-7f248d3120ee)
- [issuing_officer](https://www.keypedia.com/people/maxwell-van-tassell/dfc0fdd4-a372-41cb-8b9d-2b6a083d42e2)

Company: https://www.keypedia.com/companies/amgen-manufacturing-ltd/cecb788c-4cd6-4c26-9331-7b68b4f12369

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