FDA Inspection
AirSep Corp.AirSep Corp. – FDA Inspection, Oct 5, 2009
Record Details
This FDA Inspection record concerns AirSep Corp., with an inspection on October 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AirSep Corp.
- Inspection Date
- October 5, 2009
- Product Type
- Devices
View Company Profile
ID · f5a94619-6cf6-412b-99c6-dfb726cfdc78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 621402
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)General
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of AirSep Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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