FDA Inspection
Cynosure, LlcCynosure, Llc – FDA Inspection, Jul 27, 2018
Record Details
This FDA Inspection record concerns Cynosure, Llc, with an inspection on July 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fbd2775d-f4e1-4813-bc6c-c0f55d7e4e35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060207
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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 | |
| 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 |
| November 21, 2014 | VAI | 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 1051787 - 2017-12-08
- FDA Inspection 1003091 - 2017-03-13
- FDA Inspection 904967 - 2014-11-21
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