FDA Inspection
Asthmatx, Inc.Asthmatx, Inc. – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns Asthmatx, Inc., with an inspection on March 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Asthmatx, Inc.
- Inspection Date
- March 22, 2011
- Product Type
- Devices
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ID · a61e8867-2356-4665-ad11-b5f823c56049
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716372
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Asthmatx, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Asthmatx, Inc.
- FDA Inspection 797272 - 2012-08-22
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