# FDA 483 - Douglas Medical Products, Inc. - June 24, 2026

Source: https://www.keypedia.com/records/483/douglas-medical-products-inc/8954ca52-e084-4976-b7e9-fa20f7ce959a

> FDA 483 for Douglas Medical Products, Inc. on June 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Douglas Medical Products, Inc.
- Inspection Date: 2026-06-24
- Product Type: device
- Office Name: Chicago District Office
- Summary: Douglas Medical Products, Inc. in Mundelein, IL, a specification developer for Class II medical devices, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately apply a risk-based approach, implement effective corrective actions for particulate matter complaints, and properly control design changes. Additionally, the inspection revealed a failure to maintain adequate records for vendor evaluations.

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)
- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/douglas-medical-products-inc/bb54cbf9-d480-4877-a305-6fc6febc01dc

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