FDA Inspection
Airistar Technologies LLCAiristar Technologies LLC – FDA Inspection, Aug 30, 2011
Record Details
This FDA Inspection record concerns Airistar Technologies LLC, with an inspection on August 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Airistar Technologies LLC
- Inspection Date
- August 30, 2011
- Product Type
- Devices
View Company Profile
ID · cc79a182-0a6f-4559-a912-772e081cc052
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741934
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Airistar Technologies LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Airistar Technologies LLC
- FDA Inspection 1060745 - 2018-07-11
- FDA Inspection 917104 - 2015-03-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.