Samuel A. Mujica Trenche, MDAugust 9, 2019

FDA 483 - Samuel A. Mujica Trenche, MD - August 09, 2019

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An FDA inspection of Samuel A. Mujica Trenche, MD, a clinical investigator in Henderson, NV, revealed a significant compliance issue regarding informed consent. The firm failed to obtain legally effective informed consent by not re-consenting enrolled subjects when a new informed consent document was approved and available. This indicates a serious lapse in protecting human subjects in clinical trials.

Company: Samuel A. Mujica Trenche, MD
Inspection Date: August 9, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Jonathan R. Campos

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ID · 2686452e-ab88-401c-a5fc-126052ced2e0