FDA Inspection
Apyx Medical CorporationApyx Medical Corporation – FDA Inspection, Jul 30, 2015
Record Details
This FDA Inspection record concerns Apyx Medical Corporation, with an inspection on July 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Apyx Medical Corporation
- Inspection Date
- July 30, 2015
- Product Type
- Devices
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ID · 6ad519e8-ceb8-4bdc-8e01-7fb43288ef52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apyx Medical Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Apyx Medical Corporation
- FDA Inspection 763375 - 2012-01-18
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