FDA Inspection 1327486 — OndaMed, Inc.
The FDA completed an inspection of OndaMed, Inc. on Jul 15, 2026 in Washingtonville, 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)
- End Date
- Jul 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Washingtonville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23231 | ISO 13485:2016 Clause 8.2.6 | Evidence of conformity to the acceptance criteria not maintained |
| 23248 | ISO 13485:2016 Clause 8.3.4 | Rework records not maintained |