FDA Inspection 1295282 — Piramal Pharma Solutions Inc.
The FDA completed an inspection of Piramal Pharma Solutions Inc. on Dec 10, 2025 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2025
- Fiscal Year
- 2026
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |