Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-25.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2025 – 25 Feb 2025 | Human Drugs | 483 | View 483 → |
| 10 Sep 2019 – 13 Sep 2019 | Human Drugs | Clean | |
| 30 Apr 2018 – 4 May 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2025
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Daniel L Zheng, Ogechi C Nna
25 Feb 2025
21 CFR 211.192
Quality control unit review of records
Cited by Daniel L Zheng, Ogechi C Nna
4 May 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin, Christina A Capacci-Daniel
Investigators
FDA investigators tied to this site in the record.
Daniel L Zheng1 insp.
Ogechi C Nna1 insp.
Tonia F Bernard1 insp.
Sean R Marcsisin1 insp.
Christina A Capacci-Daniel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alnylam Pharmaceuticals Inc.'s 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat