# FDA 483 - Amgen Manufacturing Ltd - July 05, 2023

Source: https://www.keypedia.com/records/483/amgen-manufacturing-ltd/ceae345a-06d0-4a2c-9f27-1c7016f467b7

> FDA 483 for Amgen Manufacturing Ltd on July 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2023-07-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Amgen Manufacturing Ltd in Juncos, PR, was cited with three observations during an FDA inspection. The firm demonstrated inadequate control procedures for manufacturing processes, specifically regarding alarm management during visual inspection. Additionally, deficiencies were noted in the drug product stability program, including delayed study initiation and insufficient monitoring of contract manufacturing sites. Finally, the facility experienced repeated pest control failures, leading to numerous infestations in critical manufacturing and storage areas.

## Related Documents

- [483 - 2021-09-08](https://www.keypedia.com/records/483/amgen-manufacturing-ltd/4e22eb82-c1e0-40d2-9885-de04bda03b61)
- [EIR - 2019-09-27](https://www.keypedia.com/records/eir/amgen-manufacturing-ltd/f5b745d0-e63f-4419-b722-b1d9cd31b179)
- [483 - 2020-02-27](https://www.keypedia.com/records/483/amgen-manufacturing-ltd/abc3f33a-b3af-41e0-a0aa-af0692b345ae)
- [483 - 2019-04-11](https://www.keypedia.com/records/483/amgen-manufacturing-ltd/2151d238-ef8a-48d6-bb0e-e262677fe58d)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/amgen-manufacturing-ltd/2514ea02-8069-40d4-9b32-3a9649c22c06)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Ivis L. Negron Torres](https://www.keypedia.com/people/ivis-l-negron-torres/eb77f360-bb0b-4a13-a0da-b89c36ccaca9)

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