FDA Inspection 1195280 — Catalent Ontario Limited
The FDA completed an inspection of Catalent Ontario Limited on January 20, 2023 in Windsor. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Windsor (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |