FDA Inspection
Aionex, Inc.Aionex, Inc. – FDA Inspection, Nov 20, 2012
Record Details
This FDA Inspection record concerns Aionex, Inc., with an inspection on November 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aionex, Inc.
- Inspection Date
- November 20, 2012
- Product Type
- Devices
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ID · d8cb82c9-055d-4766-9ba2-7dd427b150f3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 808865
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
Showing 10 of 12 citations.
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Other FDA inspections of Aionex, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2026 | Not classified | New Orleans District Office | |
| January 11, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aionex, Inc.
- FDA Inspection 1319490 - 2026-05-06
- FDA Inspection 1198221 - 2023-01-11
- FDA Inspection 993878 - 2016-12-02
- FDA Inspection 882505 - 2014-06-09
- FDA Inspection 838660 - 2013-07-02
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