1262276
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |