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

An FDA inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, was conducted from July 18-22, 2016. This high-priority inspection focused on bioanalytical facilities for a CDER user fee pre-approval data validation and included a surveillance assessment of LC-MS activities. The inspection operated under Compliance Program 7348.001 (In Vivo Bioequivalence) and relevant regulations like 21 CFR Part 11 and 21 CFR 320.29(a).

While no official Form FDA 483 (Inspectional Observations) was issued, the inspection team discussed several areas for improvement. Observations included inadequate documentation for a specific plate map change in one study, an outlier result in method validation without an assignable cause, and chromatographic resolution concerns for a particular analyte. Inspectors also noted issues with methods transferred from sponsors that lacked sufficient documentation, making it unclear what was being measured. Procedural suggestions included adopting a more conservative approach by discarding suspect plates after potential sample transfer accidents and ensuring late entries in laboratory notebooks adhered to good documentation practices. Concerns were also raised regarding the use of "conditioning samples" for system suitability, which could introduce bias, and the value of out-of-sequence signatures on certain records. The FDA team suggested a review of product-specific guidance documents for bioequivalence studies.