FDA Inspection
Cynosure, Inc.Cynosure, Inc. – FDA Inspection, Aug 7, 2014
Record Details
This FDA Inspection record concerns Cynosure, Inc., with an inspection on August 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cynosure, Inc.
- Inspection Date
- August 7, 2014
- Product Type
- Devices
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ID · eaa16b94-784e-4444-87bb-8aa81bd8f499
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890615
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Cynosure, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2017 | Not classified | New York District Office | |
| May 11, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 781457 - 2012-05-11
- FDA Inspection 663451 - 2010-05-26
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