FDA Inspection
Van Duzen, Inc. dba MedCADVan Duzen, Inc. dba MedCAD – FDA Inspection, Aug 2, 2024
Record Details
This FDA Inspection record concerns Van Duzen, Inc. dba MedCAD, with an inspection on August 2, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8861bcd-2b4f-4474-b488-565a1ce8e59c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245727
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Van Duzen, Inc. dba MedCAD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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