FDA 483 - Litron Laboratories, LTD - June 02, 2009

Litron Laboratories, LTD in Rochester, NY, a non-clinical laboratory, was cited with two observations during an FDA inspection. The inspection revealed failures within the Quality Assurance Unit, specifically regarding inadequate inspection intervals for high-risk study steps and a lack of independence between QAU personnel and study direction. These issues indicate deficiencies in ensuring the integrity and oversight of nonclinical laboratory studies.