FDA Inspection 1304784 — PROVISIO MEDICAL INC
The FDA completed an inspection of PROVISIO MEDICAL INC on February 27, 2026 in San Diego, CA. 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
- February 27, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23240 | ISO 13485:2016 Clause 8.3.2 | Nonconforming product was not dispositioned appropriately |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |