FDA Inspection
Van Duzen, Inc. dba MedCADVan Duzen, Inc. dba MedCAD – FDA Inspection, Feb 15, 2013
Record Details
This FDA Inspection record concerns Van Duzen, Inc. dba MedCAD, with an inspection on February 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Van Duzen, Inc. dba MedCAD
- Inspection Date
- February 15, 2013
- Product Type
- Devices
View Company Profile
ID · 92ee4442-00de-45e0-8dcb-d19b0662958e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| 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 |
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