FDA Inspection
Cynosure, Inc.Cynosure, Inc. – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns Cynosure, Inc., with an inspection on May 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cynosure, Inc.
- Inspection Date
- May 11, 2012
- Product Type
- Devices
View Company Profile
ID · 35fd5b31-34c5-4f9e-b865-d940ed78482e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781457
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cynosure, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2017 | Not classified | New York District Office | |
| August 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cynosure, Inc.
- FDA Inspection 1008712 - 2017-03-10
- FDA Inspection 890615 - 2014-08-07
- FDA Inspection 663451 - 2010-05-26
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