FDA EIR - David A. Plager, M.D. - September 18, 2018

This FDA inspection, conducted at David A. Plager, M.D. from September 11-18, 2018, served as a follow-up to an earlier inspection in July 2016 that had resulted in an Official Action Indicated classification. The previous inspection uncovered multiple violations, including non-adherence to the investigational plan (such as enrolling subjects on prohibited medications, unqualified study staff, and underreporting of adverse events), failures to maintain accurate patient records, and lack of Institutional Review Board (IRB) approval for research changes. These findings led to an FDA Form 483 and an untitled letter, prompting Dr. Plager to commit to corrective actions. The purpose of the current inspection, carried out under Compliance Program 7348.811 for Clinical Investigators, was to verify the implementation of these corrective measures and evaluate the site's ongoing compliance with FDA regulations across its active studies, including Study 670. The comprehensive review covered areas such as protocol adherence, informed consent, data integrity, and investigational product accountability. Significantly, this inspection did not result in the issuance of an FDA Form 483, indicating resolution of the prior serious issues. The closing discussion, however, highlighted the importance of consistently applying Good Clinical Practice (GCP) standards. Specific points raised included proper methods for correcting errors in study documents, avoiding practices like using white-out, and ensuring subjects are adequately reminded on accurate completion of study diaries.