# Van Duzen, Inc. dba MedCAD – FDA 483, Aug 2, 2024

Source: https://www.keypedia.com/records/483/van-duzen-inc-dba-medcad/b4ec9882-3c8a-419c-a2b3-8450cb761c68

> FDA 483 for Van Duzen, Inc. dba MedCAD on August 02, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Van Duzen, Inc. dba MedCAD
- Inspection Date: 2024-08-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Van Duzen, Inc. dba MedCAD in Dallas, TX, a Class II medical device manufacturer, revealed a significant quality system deficiency. The firm failed to adequately validate the cleaning instructions for its AccuPlan System, a Class II medical device. This lack of validation poses a potential risk of patient infection, as noted in the firm's own risk analysis.

## Related Officers

- [Jacey Roy](https://www.keypedia.com/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.keypedia.com/companies/van-duzen-inc-dba-medcad/23639a02-cad0-4bd2-a9e7-016970fd114d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab