FDA Inspection 1157266 — Tower Laboratories Ltd.
The FDA completed an inspection of Tower Laboratories Ltd. on Nov 17, 2021 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 17, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montague, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |