FDA Inspection
miraDry, IncmiraDry, Inc – FDA Inspection, Aug 1, 2016
Record Details
This FDA Inspection record concerns miraDry, Inc, with an inspection on August 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- miraDry, Inc
- Inspection Date
- August 1, 2016
- Product Type
- Devices
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ID · f870c44f-a3cb-4ec7-91e1-df0ad381f159
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 978277
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of miraDry, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2015 | 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 938741 - 2015-08-17
- FDA Inspection 770221 - 2012-03-01
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