FDA Inspection 773285 — Tower Laboratories, Ltd.
The FDA completed an inspection of Tower Laboratories, Ltd. on March 15, 2012 in Centerbrook, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Centerbrook, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15952 | 21 CFR 111.113 | Quality control operations - material review, disposition |