FDA Inspection 1088553 — Sun Pharma Canada Inc.
The FDA completed an inspection of Sun Pharma Canada Inc. on May 3, 2019 in Brampton. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2019
- Fiscal Year
- 2019
- 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 |
| 2397 | 21 CFR 211.194(a)(1) | Description and Identification of Samples |
| 4576 | 21 CFR 211.192 | No written record of investigation |