FDA Inspection 1261259 — 9338-9641 Quebec Inc.
The FDA completed an inspection of 9338-9641 Quebec Inc. on Mar 14, 2025 in Boisbriand. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boisbriand (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |