FDA Inspection 834739 — Tower Laboratories, Ltd.
The FDA completed an inspection of Tower Laboratories, Ltd. on June 18, 2013 in Centerbrook, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Centerbrook, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |