Donald J Garcia, Jr. M.D.April 1, 2021

FDA 483 - Donald J Garcia, Jr. M.D. - April 01, 2021

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Record Details

An FDA inspection of Donald J Garcia, Jr. M.D., a clinical investigator in Austin, TX, revealed a significant failure to comply with regulations regarding informed consent. The firm did not ensure that informed consent was obtained from human subjects prior to conducting study-related tests, specifically urine screening for eligibility. This indicates a lapse in protecting human subjects participating in clinical trials.

Company: Donald J Garcia, Jr. M.D.
Inspection Date: April 1, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
Person: Iris C. Macinnes

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ID · 613d6380-3165-455b-a2b0-d7c43d3b711d