FDA Inspection
Aionex, Inc.Aionex, Inc. – FDA Inspection, Jul 2, 2013
Record Details
This FDA Inspection record concerns Aionex, Inc., with an inspection on July 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aionex, Inc.
- Inspection Date
- July 2, 2013
- Product Type
- Devices
View Company Profile
ID · 50eaf454-1230-45c9-9678-831c2679097d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838660
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.70(i)Software validation for automated processes
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
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 |
| November 20, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 808865 - 2012-11-20
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