FDA Inspection 1044232 — Piramal Pharma Solutions Inc.
The FDA completed an inspection of Piramal Pharma Solutions Inc. on Mar 14, 2018 in Lexington, KY. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |