FDA Inspection
Cynosure, LlcCynosure, Llc – FDA Inspection, Apr 28, 2014
Record Details
This FDA Inspection record concerns Cynosure, Llc, with an inspection on April 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cynosure, Llc
- Inspection Date
- April 28, 2014
- Product Type
- Devices
View Company Profile
ID · 5cdae620-2e2c-4800-984a-cc628556b2e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 876385
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(a)Investigator(s) not qualified
- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cynosure, Llc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2018 | Not classified | New England District Office | |
| July 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2017 | Not classified | New England District Office | |
| March 13, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Cynosure, Llc
- FDA Inspection 1295506 - 2025-12-12
- FDA Inspection 1093281 - 2018-12-14
- FDA Inspection 1060207 - 2018-07-27
- FDA Inspection 1051787 - 2017-12-08
- FDA Inspection 1003091 - 2017-03-13
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