Company
United StatesAirSep Corp., Ball Ground, GA – FDA Inspections
Inspection records and compliance data for AirSep Corp. in Ball Ground, Georgia. 2 FDA inspections on record, last inspected June 29, 2011.
Company Profile
This profile covers AirSep Corp. based in Ball Ground, Georgia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected October 5, 2009. Last inspected June 29, 2011.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 731958 |
| October 5, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 621402 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AirSep Corp.
FEI Number
3010730925
Address
2200 Airport Industrial Dr, Ball Ground, Georgia 30107, United States
Country
United States
ID: 2acff99b-f8bb-4543-8bdf-4b5280db3063