FDA Inspection
nexAir LLCnexAir LLC – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns nexAir LLC, with an inspection on September 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- nexAir LLC
- Inspection Date
- September 11, 2009
- Product Type
- Devices
View Company Profile
ID · 389ff471-f75c-470c-881d-5ee0e314f6b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614504
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of nexAir LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for nexAir LLC
- FDA Inspection 890731 - 2014-08-12
- FDA Inspection 767585 - 2012-01-26
- FDA Inspection 630713 - 2009-11-19
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.