Company
United StatesmiraDry, Inc, Santa Clara, CA – FDA Inspections
Inspection records and compliance data for miraDry, Inc in Santa Clara, California. 3 FDA inspections on record, last inspected August 01, 2016.
Company Profile
This profile covers miraDry, Inc based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 1, 2012. Last inspected August 1, 2016.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 1, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 978277 |
| August 17, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938741 |
| March 1, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 770221 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
miraDry, Inc
FEI Number
3008082710
Address
2790 Walsh Ave, Santa Clara, California 95051, United States
Country
United States
ID: 01651783-621a-484d-96dd-655bf598cc86