FDA Inspection 1276815 — Omnia Medical
The FDA completed an inspection of Omnia Medical on Jul 28, 2025 in Morgantown, WV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Morgantown, WV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |