# FDA 483 - Amgen Manufacturing Ltd - September 08, 2021

Source: https://www.globalkeysolutions.net/records/483/amgen-manufacturing-ltd/4e22eb82-c1e0-40d2-9885-de04bda03b61

> FDA 483 for Amgen Manufacturing Ltd on September 08, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2021-09-08
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Amgen Manufacturing Limited in Juncos, P.R., received a Form 483 citing significant deficiencies in quality control and documentation practices. Observations included inadequate testing of components from unqualified suppliers, failure to document production events in real-time, and a lack of thorough investigations into unexpected results and inventory discrepancies. These issues indicate a need for improved adherence to GMP regulations regarding material control, record-keeping, and quality system investigations.

## Related Documents

- [EIR - 2019-09-27](https://www.globalkeysolutions.net/records/eir/amgen-manufacturing-ltd/f5b745d0-e63f-4419-b722-b1d9cd31b179)
- [483 - 2023-07-05](https://www.globalkeysolutions.net/records/483/amgen-manufacturing-ltd/ceae345a-06d0-4a2c-9f27-1c7016f467b7)
- [483 - 2020-02-27](https://www.globalkeysolutions.net/records/483/amgen-manufacturing-ltd/abc3f33a-b3af-41e0-a0aa-af0692b345ae)
- [483 - 2019-04-11](https://www.globalkeysolutions.net/records/483/amgen-manufacturing-ltd/2151d238-ef8a-48d6-bb0e-e262677fe58d)
- [483 - 2019-09-27](https://www.globalkeysolutions.net/records/483/amgen-manufacturing-ltd/2514ea02-8069-40d4-9b32-3a9649c22c06)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/milva-melendez/164c3147-2aea-4d81-b55c-d139eab17ea4)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321