FDA Inspection 1174408 — Sonomed, Inc.
The FDA completed an inspection of Sonomed, Inc. on Jul 14, 2022 in Westbury, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 14, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |