FDA Inspection 1073073 — Patheon Softgels B.V.
The FDA completed an inspection of Patheon Softgels B.V. on November 30, 2018 in Tilburg. 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
- November 30, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tilburg (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |