774283
Tower Laboratories Ltd. — FEI 1823985
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montague, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |