FDA Inspection
Amgen Manufacturing LtdAmgen Manufacturing Ltd – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns Amgen Manufacturing Ltd, with an inspection on September 27, 2019, issued by the San Juan District Office, covering human drugs.
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ID · 626ff6fc-7155-43d9-9468-c6c2eaba8f05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1105967
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.188Prepared for each batch, include complete information
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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 |
| May 8, 2019 | Not classified | San Juan District Office | |
| April 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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