FDA Inspection 709940 — Sonomed, Inc.
The FDA completed an inspection of Sonomed, Inc. on Feb 10, 2011 in Westbury, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |