FDA Inspection
AADCO Medical Inc.AADCO Medical Inc. – FDA Inspection, Feb 22, 2023
Record Details
This FDA Inspection record concerns AADCO Medical Inc., with an inspection on February 22, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93ee377e-c3f4-4d9c-b31f-cb49945c47f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198080
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.86Acceptance status
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Other FDA inspections of AADCO Medical Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AADCO Medical Inc.
- FDA Inspection 894325 - 2014-08-13
- FDA Inspection 789227 - 2012-06-26
- FDA Inspection 583581 - 2009-04-16
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