FDA 483 - David Young, D.O. - December 19, 2017

An FDA inspection of Dr. David B. Young, D.O., a clinical investigator in Pleasant Grove, UT, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the signed statement of investigator, maintain adequate and accurate case histories, and obtain legally effective informed consent from subjects. These issues indicate a lack of control over critical aspects of clinical trial management and subject protection.