FDA Inspection
Van Duzen, Inc. dba MedCADVan Duzen, Inc. dba MedCAD – FDA Inspection, Aug 23, 2017
Record Details
This FDA Inspection record concerns Van Duzen, Inc. dba MedCAD, with an inspection on August 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 40119ee4-056e-43c5-a71e-32046a711e90
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1022962
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Van Duzen, Inc. dba MedCAD
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.