FDA 483 - East Tennessee Clinical Research, Inc - October 21, 2014

An FDA inspection of East Tennessee Clinical Research, Inc. in Rockwood, TN, a non-clinical laboratory, revealed significant deficiencies in its adherence to Good Laboratory Practices. Observations included failures in determining stability and characterizing study articles, inadequate quality assurance unit oversight, and insufficient personnel training. The firm also failed to properly document final study reports, indicating systemic issues in study integrity and record-keeping.