FDA Inspection
AirXpanders, Inc.AirXpanders, Inc. – FDA Inspection, Dec 16, 2015
Record Details
This FDA Inspection record concerns AirXpanders, Inc., with an inspection on December 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AirXpanders, Inc.
- Inspection Date
- December 16, 2015
- Product Type
- Devices
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ID · ed8bf572-356f-44dd-9d28-bf286aebed5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981336
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of AirXpanders, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for AirXpanders, Inc.
- FDA Inspection 874064 - 2014-04-16
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