# FDA 483 - Ralph A. DeFronzo - December 06, 2024

Source: https://www.keypedia.com/records/483/ralph-a-defronzo/88d10281-69a8-4ad1-a2fe-cf17cd49ac9a

> FDA 483 for Ralph A. DeFronzo on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ralph A. DeFronzo
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: During an FDA inspection conducted from December 3-6, 2024, Clinical Investigator Ralph A. DeFronzo received a Form 483 citing significant observations regarding a clinical study. The primary issues identified centered on a failure to conduct the investigation in accordance with the signed investigator statement and investigational plan. Specifically, the inspection revealed multiple instances where subjects were enrolled despite not meeting the established eligibility criteria, including discrepancies in blood pressure readings, missing laboratory results, and the presence of prohibited medications. Furthermore, the eligibility criteria used in source documents did not consistently align with those specified in the Institutional Review Board (IRB)-approved protocol. Critical violations also included failures in the informed consent process and IRB oversight. Subjects were not consented under the most current IRB-approved protocol, and re-consenting was not performed when required. A significant observation was the initiation of study-related procedures *before* subjects provided informed consent, a direct violation of 21 CFR Part 50. Additionally, major changes to the study design, such as transitioning from a double-blind, placebo-controlled trial to a pilot feasibility study where all participants received the investigational drug, were implemented without prior IRB approval. Screening procedures, like the number of blood pressure measurements, also deviated from the approved protocol. This Form 483 serves as an official communication of these observed objectionable conditions and practices. Dr. DeFronzo is expected to respond to the FDA with objections or details of corrective actions already implemented or planned to address these findings.

## Related Documents

- [483 - 2024-12-06](https://www.keypedia.com/records/483/ralph-a-defronzo/cd54f88b-5b55-4cc7-911a-7ebd4d71a334)

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Company: https://www.keypedia.com/companies/ralph-a-defronzo/ffc95dfc-47d0-45cb-8d9a-53e81cf0b244

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9