# Amgen Manufacturing Ltd – FDA Inspection, Sep 27, 2019

Source: https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/626ff6fc-7155-43d9-9468-c6c2eaba8f05
Source feed: FDA_Inspections

> FDA inspection 1105967 of Amgen Manufacturing Ltd, September 27, 2019. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR part 211. Form 483 issued. 19 other FDA inspections on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1105967
- Company Name: Amgen Manufacturing Ltd
- Inspection Date: 2019-09-27
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: New Drug Evaluation
- Product Type: Human Drugs
- Center: Human Drugs
- Office Name: San Juan District Office
- Citation Count: 2

## Related Documents

- [FDA Inspection 1294400 - 2026-04-27](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/eb707232-a564-4a67-9696-6abce212f323)
- [FDA Inspection 1209484 - 2023-07-05](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/585f98a3-6738-4615-afc2-12369c9d7390)
- [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)
- [FDA Inspection 1061201 - 2018-08-06](https://www.keypedia.com/records/fda_inspections/amgen-manufacturing-ltd/50f99ed9-7c55-4092-9b6d-506ccc3b480c)

## Related Officers

- [FDA Associated Person](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/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8