Drug factory · FDA FEI 3013754451
Alnylam Pharmaceuticals Inc.
665 Concord Ave, Cambridge, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Patisiran | Makes it | Alnylam Pharmaceuticals, Inc. | 71336-1000 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 25, 2025 inspection
- Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; manufacture.