# FDA 483 - Steven W. Boyce, M. D. - September 15, 2011

Source: https://www.keypedia.com/records/483/steven-w-boyce-m-d/3612f2d2-05b7-458d-9464-71cd60542d14

> FDA 483 for Steven W. Boyce, M. D. on September 15, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven W. Boyce, M. D.
- Inspection Date: 2011-09-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Steven W. Boyce, M.D., Clinical Investigator, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures related to IRB continuing review approval, improper informed consent documentation, and non-adherence to the investigational protocol. These issues indicate a lack of oversight and control over critical aspects of human subject protection and data integrity.

## Related Officers

- [Krista Flores](https://www.keypedia.com/people/krista-flores/c3975ea1-b83d-4035-acef-92ed684a58de)

Company: https://www.keypedia.com/companies/steven-w-boyce-m-d/c3a57dc2-22d2-41ab-9e4c-f8923e231451

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e