FDA 483 - Nicholas Ah Mew, M.D. - July 17, 2019

An FDA inspection of Nicholas Ah Mew, M.D., a clinical investigator in Washington, DC, revealed significant deficiencies in clinical trial conduct. Observations included an informed consent document that failed to describe reasonably foreseeable risks to subjects. Additionally, the firm failed to prepare and maintain accurate and complete case histories, with missing data, discrepancies, and lack of investigator review documentation.