FDA Inspection 1208520 — Techlem Medical Corporation
The FDA completed an inspection of Techlem Medical Corporation on June 22, 2023 in Mississauga. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 22, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |