Company
United StatesVan Duzen, Inc. dba MedCAD, Dallas, TX – FDA Inspections
Inspection records and compliance data for Van Duzen, Inc. dba MedCAD in Dallas, Texas. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 02, 2024.
Company Profile
This profile covers Van Duzen, Inc. dba MedCAD based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected February 15, 2013. Last inspected August 2, 2024.
Most cited issue areas
- Lack of or inadequate process validation4 inspections
- Lack of or inadequate procedures2 inspections
- Lack of Written MDR Procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1245727 |
| January 30, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1077558 |
| August 23, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1022962 |
| February 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 818525 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Van Duzen, Inc. dba MedCAD
FEI Number
3009196021
Address
501 S 2nd Ave Ste 900, Dallas, Texas 75226, United States
Country
United States
ID: 23639a02-cad0-4bd2-a9e7-016970fd114d