FDA Inspection 1268776 — Catalent Ontario Limited
The FDA completed an inspection of Catalent Ontario Limited on May 2, 2025 in Strathroy. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 2, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Strathroy (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |