FDA EIR - Q2 SOLUTIONS - June 29, 2018

An FDA inspection of Q2 Solutions in Ithaca, NY, was conducted from June 25 to June 29, 2018. This pre-approval inspection, under the Bioresearch Monitoring (BIMO) Compliance Program for In Vivo Bioequivalence, focused on method validation and sample analysis for in vivo pharmacokinetic studies supporting new drug applications. The audit encompassed Standard Operating Procedures, training records, laboratory data, and overall bioanalytical practice.

Critically, the inspection concluded without the issuance of a Form FDA 483, indicating that no objectionable conditions were found at Q2 Solutions. While no violations were attributed to the firm, the auditors noted several discrepancies in sample identities and documentation originating from clinical sites, such as switched pre-dose/post-dose labels, missing subject IDs, and inconsistent collection times. Q2 Solutions effectively identified and communicated these issues to the study sponsor. Minor freezer temperature excursions were also observed but determined not to impact sample stability due to the nature of storage and sample stability data. As a result, no formal regulatory actions were required from Q2 Solutions.