FDA EIR - Alberto R. Yataco, M.D. - June 06, 2007

An FDA inspection of Alberto R. Yataco, M.D., operating as International Research Center (IRC), LLC in Towson, MD, was conducted from May 29 to June 6, 2007. This comprehensive "for-cause" inspection focused on a schizophrenia drug study and other psychiatric studies, adhering to regulations outlined in 21 CFR Parts 50, 56, and 312. The inspection resulted in a one-item FDA Form 483, indicating that the investigational plan was not followed. Specifically, one subject was enrolled despite not meeting protocol-defined eligibility criteria, and a required pregnancy test for a female subject at an early termination visit was not performed. Additional concerns discussed included maintaining an inaccurate FDA Form 1572 by listing sub-investigators who only consulted and were not removed upon their departure, and initiating study procedures at a second inpatient facility without prior Institutional Review Board (IRB) approval. Other issues involved missing ECGs for one subject due to equipment malfunction and instances where pre-dose ECGs appeared to be conducted after dosing. The consent forms also lacked disclosure that FDA might inspect subject records. Dr. Yataco committed to providing a written response to the FDA 483 and agreed to improve practices regarding accurate FDA 1572 documentation, obtaining timely IRB approvals for site changes, and ensuring precise documentation of dosing times and comprehensive consent forms.