FDA Inspection 1023290 — Soterix Medical, Inc.
The FDA completed an inspection of Soterix Medical, Inc. on August 24, 2017 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |