# FDA 483 - 3DPX Medical - July 28, 2022

Source: https://www.keypedia.com/records/483/3dpx-medical/3035408d-7445-4d71-bf58-be48f1861e30

> FDA 483 for 3DPX Medical on July 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3DPX Medical
- Inspection Date: 2022-07-28
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of 3DFX Medical, a contract manufacturer in Chicago, IL, revealed significant quality system deficiencies. The firm failed to adequately document in-process inspections and tests, validate manufacturing processes and equipment, and maintain proper document control procedures. These issues indicate a lack of control over critical aspects of medical device manufacturing.

## Related Officers

- [Brittani N. Franklin](https://www.keypedia.com/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.keypedia.com/companies/3dpx-medical/0cb0cecb-e3a4-4d00-a3a3-fab73a9eca85

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669