FDA EIR - ICON Laboratory Services, Inc. - July 22, 2016

An FDA pre-approval data validation inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, was conducted from July 18-22, 2016. The inspection focused on bioanalytical records for two studies, including a high-priority bioequivalence study, and a surveillance assessment of LC-MS activities. The regulatory framework for the inspection included Compliance Program 7348.001 (In Vivo Bioequivalence) and referenced 21 CFR Part 11 and 21 CFR 320.29(a) related to bioanalytical method validation and bioequivalence studies. Notably, a Form FDA 483, Inspectional Observations, was not issued. However, the FDA team discussed several observations and recommendations with management. These included concerns regarding inadequate documentation for a transferred bioanalytical method, unclear measurement specificity, and undocumented plate map changes in one study. The FDA also recommended more conservative practices for handling suspected sample transfer accidents and advised against using "conditioning samples" for system suitability to avoid potential bias. Further suggestions involved improving documentation practices for late entries in laboratory notebooks and reviewing FDA's product-specific guidances. Management engaged in polite discussion regarding these observations, but no formal violations or required actions were documented.