FDA EIR - Q2 SOLUTIONS - June 29, 2018

An FDA Bioresearch Monitoring (BIMO) pre-approval inspection of Q2 Solutions' Ithaca, NY facility was conducted from June 25-29, 2018. The inspection, performed under Compliance Program 7348.003 for In Vivo Bioequivalence, aimed to assess method validation and sample analysis activities supporting a New Drug Application. The scope included reviewing Standard Operating Procedures, training records, method validation, laboratory notebooks, raw data, and correspondence. While the inspection team noted some temperature excursions in short-term storage freezers and identified several discrepancies in sample identities (e.g., switched dose information, missing IDs) originating from clinical sites, Q2 Solutions' internal controls identified these issues and engaged with the sponsor for resolution. Importantly, the inspection concluded without the issuance of a Form FDA 483, Inspectional Observations. This signifies that no objectionable conditions requiring immediate regulatory action were observed by the FDA. Therefore, no specific regulatory actions were required from the firm as a direct result of this inspection.