# Amgen Manufacturing Ltd – FDA Inspection, May 10, 2017

Source: https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/ca324b01-0cad-45dd-bfa1-ccedff3383f1
Source feed: FDA_Inspections

> FDA inspection 1016325 of Amgen Manufacturing Ltd, May 10, 2017. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR part 211. Form 483 issued. 19 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1016325
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2017-05-10
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 2

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- [FDA Inspection 1209484 - 2023-07-05](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/585f98a3-6738-4615-afc2-12369c9d7390)
- [FDA Inspection 1105967 - 2019-09-27](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/626ff6fc-7155-43d9-9468-c6c2eaba8f05)
- [FDA Inspection 1093715 - 2019-05-08](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/e1972aa3-6bf7-409e-bc6b-6a62651684a7)
- [FDA Inspection 1085900 - 2019-04-11](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/a48ae540-0c6d-47fe-88af-9d124f4994aa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jose-a-lopez-rubet/1d1f18e7-bb35-442f-829e-e21b0c081bfa)
- Issuing Officer

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c