1119942
Sterimax, Inc. — FEI 3011394370
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakville (Canada)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |