483
Litron Laboratories, LTDLitron Laboratories, LTD – FDA 483, Jun 2, 2009
Record Details
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.
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ID · 1481190c-1d3c-447b-91f1-3d56d687e9c3
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