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

Source: https://www.globalkeysolutions.net/records/483/ralph-a-defronzo/cd54f88b-5b55-4cc7-911a-7ebd4d71a334

> 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: Division of Human and Animal Food Operations - West III
- Summary: Ralph A. DeFronzo, M.D., Clinical Investigator, in San Antonio, TX, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures to ensure subjects met eligibility criteria, obtain proper informed consent, and adhere to IRB-approved protocols and screening procedures. These issues indicate a serious lack of adherence to clinical trial regulations and ethical standards.

## Related Officers

- [Ruth E. Medcalf](https://www.globalkeysolutions.net/people/ruth-e-medcalf/71a61d32-807b-4b73-9ea7-b59287e14e56)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab