FDA Inspection 1170205 — The See Clear Company
The FDA completed an inspection of The See Clear Company on May 24, 2022 in Peachtree Corners, GA. 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
- May 24, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peachtree Corners, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |