Company
United StatesAirXpanders, Inc., Palo Alto, CA – FDA Inspections
Inspection records and compliance data for AirXpanders, Inc. in Palo Alto, California. 2 FDA inspections on record, last inspected December 16, 2015.
Company Profile
This profile covers AirXpanders, Inc. based in Palo Alto, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 16, 2014. Last inspected December 16, 2015.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for distribution1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 981336 |
| April 16, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 874064 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AirXpanders, Inc.
FEI Number
3009130440
Address
1047 Elwell Ct, Palo Alto, California 94303, United States
Country
United States
ID: c515edb1-9303-4a0b-9568-b8f1a4773c99