FDA Inspection 1084594 — Duchesnay Inc.
The FDA completed an inspection of Duchesnay Inc. on March 29, 2019 in Blainville. 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
- March 29, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Blainville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |