FDA Inspection 904967 — Cynosure, LLC
The FDA completed an inspection of Cynosure, LLC on Nov 21, 2014 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
- Nov 21, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 5802 | 21 CFR 1002.13 | Lack of required elements |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |