FDA 483 - ICON Laboratory Services, Inc. - July 22, 2016

This FDA inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, conducted from July 18-22, 2016, focused on a bioanalytical facility for a pre-approval data validation and surveillance of LC-MS activities. While no Form FDA 483 was issued, inspectors discussed several observations with management. The inspection operated under Compliance Program 7348.001 (In Vivo Bioequivalence), referencing regulatory requirements in 21 CFR Part 11 and 21 CFR 320.29(a), and FDA's Bioanalytical Method Validation guidance. Key observations included inadequate documentation for plate map changes in one analytical run and insufficient records for a transferred bioanalytical method, making it unclear what was being measured. Inspectors suggested more conservative actions for suspected sample transfer accidents, such as discarding suspect plates. Concerns were raised regarding out-of-sequence dates for signatures and the potential for bias from using "conditioning samples" for system suitability. Documentation practices, specifically late entries on signed-off notebook pages, were noted as needing improvement. Other points included an unassigned outlier in method validation QC data and chromatographic resolution issues for certain analytes. There were no formal required actions as an FDA 483 was not issued. However, the FDA team provided recommendations during the close-out meeting to improve data integrity, documentation, method validation, and sample handling practices, emphasizing adherence to FDA guidances.