FDA Inspection 1295860 — Pro2Health, Inc.
The FDA completed an inspection of Pro2Health, Inc. on Dec 18, 2025 in Lakewood, OH. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakewood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |