FDA Inspection
Amgen Manufacturing LtdAmgen Manufacturing Ltd – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns Amgen Manufacturing Ltd, with an inspection on September 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amgen Manufacturing Ltd
- Inspection Date
- September 11, 2009
- Product Type
- Drugs
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ID · 2e17101e-64fc-4638-bff5-e77850dc57e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611529
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Amgen Manufacturing Ltd
19| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2026 | Not classified | San Juan District Office | |
| July 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | VAI | San Juan District Office | New Drug Evaluation |
| May 8, 2019 | Not classified | San Juan District Office | |
| April 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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