1118668
TOLMAR, Inc. — FEI 3010755927
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Windsor, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |