FDA Inspection 1261312 — Genzyme Corporation
The FDA completed an inspection of Genzyme Corporation on Feb 14, 2025 in Northborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 4576 | 21 CFR 211.192 | No written record of investigation |