FDA Inspection 748354 — Catalent Ontario Limited
The FDA completed an inspection of Catalent Ontario Limited on September 16, 2011 in Windsor. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Windsor (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |