# FDA 483 - Amgen Manufacturing Ltd - May 10, 2017

Source: https://www.keypedia.com/records/483/amgen-manufacturing-ltd/90311ed7-7358-4c93-a318-71514a142128

> FDA 483 for Amgen Manufacturing Ltd on May 10, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2017-05-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Amgen Manufacturing Limited in Juncos, PR, was cited for deficiencies in its quality system during an inspection of its human drug manufacturing facility. The firm failed to adequately investigate product complaints for trends and causes, particularly for products like Enbrel and Repatha. Additionally, the annual product review for Enbrel did not include a required evaluation of complaints, despite distributed batches being within shelf life.

## 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

- [Wilmary Negron Rodriguez](https://www.keypedia.com/people/wilmary-negron-rodriguez/e7bb04eb-ed58-4e4c-932d-1069c76c0215)
- [Jose R. Lopez](https://www.keypedia.com/people/jose-r-lopez/f4e8e5fa-4765-4d8b-828d-32c202f8dadc)

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