# FDA 483 - Wilfrido A. Benitez, M.D. - July 21, 2022

Source: https://www.keypedia.com/records/483/wilfrido-a-benitez-md/d6bdcb4b-e855-44ce-a037-630b7ee3f898

> FDA 483 for Wilfrido A. Benitez, M.D. on July 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wilfrido A. Benitez, M.D.
- Inspection Date: 2022-07-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Wilfrido Benitez, M.D. in Hialeah, FL, a clinical investigator, revealed significant deviations from investigational plans and protocols. The observations indicate a failure to ensure subjects completed treatment courses, properly process baseline samples, correctly randomize subjects, and review critical screening laboratory values prior to administering investigational product. These issues raise concerns about the integrity and reliability of the clinical study data.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)
- [investigator](https://www.keypedia.com/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)

Company: https://www.keypedia.com/companies/wilfrido-a-benitez-md/9dc7bf98-5a9b-4e1d-a72a-b940fac3a0b2

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