1287196
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 16, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alma, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |