FDA 483 - Elly R. Lee MD - July 29, 2013

An FDA inspection of Elly R. Lee, M.D., a clinical investigator in Irvine, CA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans and protocols, leading to subject enrollment errors and incomplete questionnaire administration. Additionally, the firm failed to prepare and maintain accurate case histories, with numerous discrepancies found between source documents and electronic case report forms for multiple subjects.