FDA Inspection
AireRx Healthcare, LLCAireRx Healthcare, LLC – FDA Inspection, Apr 13, 2012
Record Details
This FDA Inspection record concerns AireRx Healthcare, LLC, with an inspection on April 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AireRx Healthcare, LLC
- Inspection Date
- April 13, 2012
- Product Type
- Devices
View Company Profile
ID · 5719f021-96c4-4c24-b340-d4a03efa35f1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 778229
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of AireRx Healthcare, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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