FDA Inspection
Alnylam Pharmaceuticals Inc.Alnylam Pharmaceuticals Inc. – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns Alnylam Pharmaceuticals Inc., with an inspection on May 4, 2018, issued by the New England District Office, covering human drugs.
- People
- Christina A. Capacci-Daniel (Issuing Officer)
- Sean R. Marcsisin (FDA Associated Person)
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ID · 1691a345-79e1-4df1-8ec0-180e5d67002c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050730
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Alnylam Pharmaceuticals Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2025 | VAI | New England District Office | Drug Quality Assurance |
| September 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alnylam Pharmaceuticals Inc.
- FDA Inspection 1262276 - 2025-02-25
- FDA Inspection 1109687 - 2019-09-13
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