FDA Inspection 774283 — Tower Laboratories Ltd.
The FDA completed an inspection of Tower Laboratories Ltd. on Mar 21, 2012 in Montague, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- 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 |