FDA Inspection 897644 — Patheon UK Limited
The FDA completed an inspection of Patheon UK Limited on September 12, 2014 in Swindon. 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 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Swindon (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |