FDA Inspection
AirSep Corp.AirSep Corp. – FDA Inspection, Jun 29, 2011
Record Details
This FDA Inspection record concerns AirSep Corp., with an inspection on June 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AirSep Corp.
- Inspection Date
- June 29, 2011
- Product Type
- Devices
View Company Profile
ID · e6d6e0d6-0195-4757-b0de-a20327eaaf4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731958
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of AirSep Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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