FDA EIR - QPS, LLC - December 08, 2017

The FDA conducted a high-priority pre-approval data validation and surveillance inspection of QPS, LLC, a bioanalytical facility in Newark, DE, from December 4 to December 8, 2017. The inspection, under Compliance Program 7348.001 (In Vivo Bioequivalence), audited data for biologics (PHSA 351(k), 21 CFR Part 601) and drugs (FDCA, 21 CFR Part 320), with guidance from Bioanalytical Method Validation recommendations. Notably, no Form FDA 483 (Inspectional Observations) was issued during this inspection, indicating an absence of formal regulatory violations. A previous inspection in December 2016 had cited issues with analyte stability, which were reported as resolved. During the current audit, inspectors identified several discussion points for management consideration. These included inconsistent documentation of sample handling conditions at clinical sites prior to QPS receipt. Concerns were also raised regarding measurable pre-dose concentrations of certain analytes in patient samples, which QPS had re-assayed but not fully investigated for underlying mechanisms. Additionally, the report highlighted unaddressed potential interferences in assay robustness and the impact of the referral process for neutralizing antibody testing on data interpretation. While no immediate corrective actions were mandated, QPS management was invited to provide post-inspectional correspondence on these observations, encouraging future operational enhancements.