FDA Inspection
Van Duzen, Inc. dba MedCADVan Duzen, Inc. dba MedCAD – FDA Inspection, Jan 30, 2019
Record Details
This FDA Inspection record concerns Van Duzen, Inc. dba MedCAD, with an inspection on January 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c00d99be-c0d5-439d-a3ea-f85d0a8c1018
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077558
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Van Duzen, Inc. dba MedCAD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | VAI | Center for Devices and Radiological Health | Compliance: 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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