Dr. Bruce G. Rankin, DOSeptember 22, 2023

FDA 483 - Dr. Bruce G. Rankin, DO - September 22, 2023

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Record Details

An FDA inspection of Dr. Bruce G. Rankin, DO, a bioequivalent clinical facility in Deland, FL, revealed a significant issue regarding the conduct of an investigation. The firm failed to retain reserve samples for test or reference products as required by the investigational plan and protocol. This indicates a lapse in adherence to study protocols and good clinical practices.

Company: Dr. Bruce G. Rankin, DO
Inspection Date: September 22, 2023
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Emily A. Baldwin (investigator)

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ID · 08cf5ded-135d-4c36-a218-5ccc4f3bfd61