FDA Inspection 1180887 — Sun Pharma Canada Inc.
The FDA completed an inspection of Sun Pharma Canada Inc. on Sep 16, 2022 in Brampton. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brampton (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |