FDA Inspection 1307926 — Medivis, Inc.
The FDA completed an inspection of Medivis, Inc. on March 3, 2026 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23122 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not conducted on representative product |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |