# FDA 483 - Donna S. Hrozencik, M.D. - January 26, 2022

Source: https://www.keypedia.com/records/483/donna-s-hrozencik-md/5925eef7-8bb3-4e1b-b652-74c67b24da7c

> FDA 483 for Donna S. Hrozencik, M.D. on January 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donna S. Hrozencik, M.D.
- Inspection Date: 2022-01-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 report details significant deficiencies at Donna S. Hrozencik, M.D., a clinical investigator site in Canton, MI, following an inspection from January 13-26, 2022. The inspection revealed multiple failures in conducting an investigational study, including inadequate IRB reporting and approval, non-adherence to the investigational plan, poor record-keeping, and insufficient record retention. These issues indicate a concerning lack of oversight and compliance with regulatory requirements for human subject protection and data integrity.

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Company: https://www.keypedia.com/companies/donna-s-hrozencik-md/fe03c1d6-7ed7-4fbe-bd5e-ea103d817373

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0