FDA Inspection 953137 — Jubilant Draximage Inc.
The FDA completed an inspection of Jubilant Draximage Inc. on December 17, 2015 in Kirkland. 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
- December 17, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kirkland (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4576 | 21 CFR 211.192 | No written record of investigation |