FDA EIR - Alberto R. Yataco, M.D. - April 06, 2009

An FDA inspection of Alberto R. Yataco, M.D., operating as the International Research Center (IRC) in Towson, MD, took place from March 30 to April 6, 2009. Conducted by Investigators Cynthia A. Harris and Rachel C. Harrington, this Bioresearch Monitoring inspection specifically reviewed a clinical investigator and a study protocol under an Investigational New Drug (IND) framework. At the inspection's conclusion, a Form FDA-483, "Inspectional Observations," was issued to Dr. Yataco, indicating the identification of practices or conditions that deviated from regulatory requirements. While the precise nature of these violations and the specific required actions are not detailed in the publicly available portions of this report due to extensive redactions, the issuance of a FDA-483 signifies the need for the firm to address these observations. It is also noted that a prior inspection of Dr. Yataco, from May 29 to June 6, 2007, received a "Voluntary Action Indicated" (VAI) classification. The International Research Center, founded in 1999, specializes in Phase II and III clinical trials, typically managing a small number of active studies with Dr. Yataco serving as the principal investigator for all research conducted at the site.