FDA Inspection 1050567 — Tower Laboratories Ltd.
The FDA completed an inspection of Tower Laboratories Ltd. on May 2, 2018 in Montague, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montague, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3577 | 21 CFR 211.101(b)(4) | Subdivided component/container/finished drug |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |