East Tennessee Clinical Research, Inc – FDA EIR, Oct 21, 2014

An FDA inspection of East Tennessee Clinical Research, Inc (ETCR) was conducted from October 9-21, 2014, as both a surveillance and directed inspection under Good Laboratory Practice (GLP) regulations (21 CFR Part 58). This inspection followed a previous one in 2012 which also identified significant deficiencies. The recent inspection found multiple issues outlined in an FDA-483. Key violations included the failure to determine the stability of test and control articles before or during the study, and insufficient documentation for the characterization of these articles, specifically lacking raw data and methods of synthesis. The Quality Assurance Unit (QAU) failed to inspect contracted facilities performing study procedures. Furthermore, ETCR did not ensure all personnel involved in GLP studies received adequate training, as evidenced by untrained staff participating in blood collections and necropsies. The final study report was deficient, omitting the names of all participating scientists and professionals, and failing to include signed and dated reports from some individuals. Lastly, the QAU's standard operating procedures for conducting internal audits and preparing assurance statements were deemed inadequate. Management committed to correcting all identified deficiencies, including obtaining missing data from sponsors, developing new SOPs for contractor qualification and QAU audits, providing comprehensive staff training, and amending the final study report to include all personnel and their signed reports. A written response addressing these observations was promised within 15 days.