FDA EIR - Q2 SOLUTIONS - June 29, 2018

The FDA conducted a five-day pre-approval inspection of Q2 Solutions in Ithaca, NY, from June 25 to June 29, 2018. This inspection was performed under the Bioresearch Monitoring Compliance Program for In Vivo Bioequivalence, evaluating the firm's bioanalytical practices for a New Drug Application. The assessment covered method validation and sample analysis, including a thorough review of standard operating procedures, training, and data. Although no formal violations were cited and a Form FDA 483 (Inspectional Observations) was not issued, the audit noted observations. These included numerous temperature excursions in freezers used for short-term sample storage, though Q2 provided explanations regarding door openings and sample stability. Additionally, while Q2's internal sample management processes were found adequate, inspectors identified several discrepancies in sample identities originating from clinical sites for certain studies, such as swapped pre/post-dose information and missing subject IDs. Q2 staff had proactively identified and corresponded with study sponsors to clarify these external discrepancies. No specific regulatory actions were mandated for the firm following this inspection.