FDA Inspection 778400 — Cynosure, LLC
The FDA completed an inspection of Cynosure, LLC on Apr 25, 2012 in Westford, MA. 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
- Apr 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |