FDA Inspection 1201102 — CANADIAN GENERAL FILTERS LIMITED
The FDA completed an inspection of CANADIAN GENERAL FILTERS LIMITED on March 16, 2023 in Scarborough. 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
- March 16, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |