FDA Inspection
Alnylam Pharmaceuticals Inc.Alnylam Pharmaceuticals Inc. – FDA Inspection, Feb 25, 2025
Record Details
This FDA Inspection record concerns Alnylam Pharmaceuticals Inc., with an inspection on February 25, 2025, issued by the New England District Office, covering human drugs.
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ID · f171eb1e-7893-4b06-a4b1-a428da24972b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262276
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.192Quality control unit review of records
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Other FDA inspections of Alnylam Pharmaceuticals Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2018 | VAI | New England District Office | New Drug Evaluation |
Other documents for Alnylam Pharmaceuticals Inc.
- FDA Inspection 1109687 - 2019-09-13
- FDA Inspection 1050730 - 2018-05-04
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