FDA Inspection 1174359 — Patheon Puerto Rico, Inc.
The FDA completed an inspection of Patheon Puerto Rico, Inc. on July 12, 2022 in Manati, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |