FDA Inspection
RX Air Industries LLC.RX Air Industries LLC. – FDA Inspection, May 19, 2011
Record Details
This FDA Inspection record concerns RX Air Industries LLC., with an inspection on May 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RX Air Industries LLC.
- Inspection Date
- May 19, 2011
- Product Type
- Devices
View Company Profile
ID · bcceb4f5-bba0-4961-863d-5fb3052fafb9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 725006
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RX Air Industries LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for RX Air Industries LLC.
- FDA Inspection 808052 - 2012-11-19
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