FDA Inspection
AEI Technologies, IncAEI Technologies, Inc – FDA Inspection, Jan 29, 2025
Record Details
This FDA Inspection record concerns AEI Technologies, Inc, with an inspection on January 29, 2025, issued by the Dallas District Office, covering medical devices & rad health.
- Office
- Dallas District Office
- Person
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ID · 8de5ed0e-c2dc-4e5b-b115-7dfdf0a19d47
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259506
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AEI Technologies, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | Not classified | Dallas District Office | |
| August 3, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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