Kenia Castro, M.D.January 7, 2022

FDA 483 - Kenia Castro, M.D. - January 07, 2022

Record Details

Reliable Clinical Research, LLC in Hialeah, FL, was cited for deficiencies in conducting a clinical investigation. The firm randomized subjects who did not meet inclusion/exclusion criteria, violating the investigational plan. Additionally, the firm failed to promptly report two Serious Adverse Events (SAEs) to the sponsor as required by the study protocol.

Company: Kenia Castro, M.D.
Inspection Date: January 7, 2022
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Sheri L. Stephenson (issuing_officer)

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ID · d45569f4-7d4d-470e-bd61-19c3b1227ca1