FDA Inspection 1218529 — Contour Healer LLC
The FDA completed an inspection of Contour Healer LLC on September 15, 2023 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Virginia Beach, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |