FDA Inspection
Amgen Manufacturing LtdAmgen Manufacturing Ltd – FDA Inspection, May 10, 2017
Record Details
This FDA Inspection record concerns Amgen Manufacturing Ltd, with an inspection on May 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- jose a lopez rubet (Investigator)
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · ca324b01-0cad-45dd-bfa1-ccedff3383f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016325
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
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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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