FDA Inspection
Syneron, Inc.Syneron, Inc. – FDA Inspection, Aug 15, 2018
Record Details
This FDA Inspection record concerns Syneron, Inc., with an inspection on August 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4c5de985-96f1-4697-85b1-2c08b8cff778
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062605
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Syneron, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 5, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 6, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Syneron, Inc.
- FDA Inspection 895132 - 2014-09-12
- FDA Inspection 733570 - 2011-07-05
- FDA Inspection 675278 - 2010-08-06
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