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 NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |