FDA EIR - McLaughlin, Vallerie, MD - January 06, 2009

An FDA inspection of Dr. Vallerie McLaughlin, MD, located in Ann Arbor, MI, was conducted from December 9, 2008, to January 6, 2009. The inspection focused on compliance with regulatory guidelines for clinical investigations. Upon conclusion, an FDA-483, Inspectional Observations, containing five significant findings, was issued. Key violations included a failure to maintain accurate case histories, specifically concerning the reporting of serious adverse events, erroneous data entry, and unauthorized data alterations, which contravene Good Clinical Practices (GCPs). The investigation also revealed that the study was not conducted according to the approved investigational plan, citing issues like unperformed 6-minute walk tests within specified timelines, missing pregnancy tests and vital sign measurements, and improper subject consenting and replacement. Furthermore, Dr. McLaughlin failed to report adverse events potentially caused by the investigational drug to the sponsor and did not promptly inform the Institutional Review Board (IRB) of unanticipated problems involving risk to human subjects, including both serious and other adverse events. A lack of written records for the disposition of the investigational drug was also noted. Dr. McLaughlin was advised of her right to submit a formal response to the FDA-483 observations to the Detroit District Office.