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 OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 21, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- 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 |