FDA Inspection 1065689 — Patheon Inc.
The FDA completed an inspection of Patheon Inc. on Sep 14, 2018 in Whitby. 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: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Whitby (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |