FDA Inspection 857050 — Contour Healer LLC
The FDA completed an inspection of Contour Healer LLC on November 5, 2013 in Virginia Beach, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Virginia Beach, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |