# FDA 483 - Edmundowicz, Dr Steven - October 09, 2025

Source: https://www.globalkeysolutions.net/records/483/edmundowicz-dr-steven/94b423fd-0589-417b-bc80-3525a4029dd8

> FDA 483 for Edmundowicz, Dr Steven on October 09, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edmundowicz, Dr Steven
- Inspection Date: 2025-10-09
- Product Type: other
- Office Name: Denver District Office
- Summary: The University of Colorado Denver Hospital received a Form FDA 483 with five observations during an inspection of a clinical study involving a gastric balloon system. The inspection revealed significant issues including non-adherence to the investigational plan, inaccurate and incomplete subject records, and failures in timely reporting to the Institutional Review Board. These findings indicate serious deficiencies in the conduct and oversight of the clinical trial.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/edmundowicz-dr-steven/8790bc54-e3c6-4165-a1d4-a6b67c236dc6

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face