FDA 483 - Maria W. Greenwald, MD - November 01, 2019

An FDA inspection of Maria Greenwald, MD, a clinical investigator in Palm Desert, CA, revealed a significant deficiency in record-keeping practices. The firm failed to prepare or maintain adequate and accurate case histories, specifically regarding the availability of required chest x-rays and discrepancies in subject randomization records. This indicates a severity related to data integrity and protocol adherence in clinical investigations.