FDA EIR - East Tennessee Clinical Research, Inc - May 29, 2012

An FDA inspection of East Tennessee Clinical Research, Inc. (ETCR) was conducted from May 23-29, 2012, focusing on the company's compliance with Good Laboratory Practice (GLP) regulations, specifically concerning a target animal safety study (DOM001). The inspection revealed multiple deficiencies. Key issues included the Quality Assurance Unit (QAU) not being entirely independent of the study's conduct, as required by 21 CFR 58.35(a). The firm also failed to adequately document the testing, calibration, and standardization of laboratory equipment, such as the hematology analyzer, lacking records of quality control checks, expiration dates, and lot numbers for standards (21 CFR 58.63(a)). Furthermore, ETCR lacked proper characterization documentation for the control article (placebo) used in the study (21 CFR 58.105(a)). The QAU failed to monitor contracted laboratory facilities to ensure their compliance with GLP regulations and the study protocol (21 CFR 58.35(a)). Access to the firm's archives was found to be insufficiently controlled, with the existing Standard Operating Procedure (SOP) allowing all employees access during business hours, contrary to regulatory requirements for authorized personnel only (21 CFR 58.190(d)). Lastly, the firm did not consistently maintain a historical file of SOPs with documented routine reviews, failing to adhere to its own internal procedures. Management acknowledged the observations and committed to corrective actions, although specific timelines were not provided.