FDA Inspection 1295884 — MassBiologics
The FDA completed an inspection of MassBiologics on December 18, 2025 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |