# FDA 483 - Kasia Osadzinska, MD - June 15, 2021

Source: https://www.keypedia.com/records/483/kasia-osadzinska-md/29536a33-4ad1-45b3-b416-14ed032ad304

> FDA 483 for Kasia Osadzinska, MD on June 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kasia Osadzinska, MD
- Inspection Date: 2021-06-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected Cornerstone Research Institute (Kasia Osadzinska, MD) in Altamonte Springs, FL, regarding a Phase 3 clinical trial (Protocol HTX-011-302). The inspection revealed that the investigation was not conducted in accordance with the investigational plan. Specifically, subjects received rescue medication doses exceeding protocol limits and ineligible subjects were enrolled into the study.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ladislav-kermet/b84bf1f8-d79b-40c7-9c18-c7a8f8f13c45)

Company: https://www.keypedia.com/companies/kasia-osadzinska-md/c0b79525-f09d-496c-be94-e7ef1cad3560

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6