FDA Inspection
miraDry, IncmiraDry, Inc – FDA Inspection, Aug 17, 2015
Record Details
This FDA Inspection record concerns miraDry, Inc, with an inspection on August 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- miraDry, Inc
- Inspection Date
- August 17, 2015
- Product Type
- Devices
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ID · bbca9e6c-2154-42ad-bf12-a443bc466e39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938741
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of miraDry, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for miraDry, Inc
- FDA Inspection 978277 - 2016-08-01
- FDA Inspection 770221 - 2012-03-01
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