FDA Inspection 957414 — Ropack, Inc. (Site A & B)
The FDA completed an inspection of Ropack, Inc. (Site A & B) on January 21, 2016 in Anjou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 21, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anjou (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |