FDA Inspection 876385 — Cynosure, LLC
The FDA completed an inspection of Cynosure, LLC on Apr 28, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 28, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Westford, MA (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |