FDA 483 - East Tennessee Clinical Research, Inc - May 26, 2023

An FDA inspection of East Tennessee Clinical Research, Inc., a non-clinical laboratory facility in Rockwood, TN, revealed two significant observations. The firm was cited for inadequate calibration of equipment used for data generation and for its quality assurance unit's failure to properly sign audit reports and statements for final study reports. These issues indicate deficiencies in laboratory controls and quality assurance practices.