FDA Inspection 815281 — Safecross First Aid Ltd
The FDA completed an inspection of Safecross First Aid Ltd on Jan 24, 2013 in North York. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North York (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |