# FDA 483 - Amgen Manufacturing Ltd - September 27, 2019

Source: https://www.keypedia.com/records/483/amgen-manufacturing-ltd/2514ea02-8069-40d4-9b32-3a9649c22c06

> FDA 483 for Amgen Manufacturing Ltd on September 27, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2019-09-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA Pre-Approval Inspection of Amgen Manufacturing Limited in Juncos, PR, identified two significant observations. The firm was cited for failing to maintain complete batch production and control records and for not establishing adequate control procedures to validate manufacturing processes, specifically regarding process performance qualification documentation.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6