FDA 483 - David R. Young - March 18, 2013

An FDA inspection of David R. Young, a GLP Non-Clinical Bioresearch Facility in Turlock, CA, revealed significant deficiencies in Good Laboratory Practice (GLP) regulations. Observations included failures in assuring test and control article integrity, inadequate quality assurance unit oversight of studies and final reports, and issues with record-keeping and protocol adherence. These findings indicate a lack of robust controls and documentation practices essential for non-clinical laboratory studies.