FDA EIR - Quotient Sciences-Miami, Inc - May 30, 2019

An FDA inspection of Quotient Sciences-Miami, Inc. (QSM) took place from May 22 to May 30, 2019. This comprehensive premarket Bioequivalence and Bioavailability (BIMO) inspection, assigned by the Center for Drug Evaluation and Research, focused on an in vivo clinical study. The inspection encompassed a review of study administration, protocols, Institutional Review Board (IRB) approvals, subject selection, investigational medication controls, and data evaluation, consistent with Compliance Program 7348.003. Initially, a Form FDA 483 was issued to QSM for not retaining samples of the study drugs, citing regulations 21 CFR 320.38 and 320.63. However, the Establishment Inspection Report was later amended. After further agency review, the FDA concurred with QSM's position that the clinical study was not a bioequivalence study, rendering the retention sample regulations inapplicable. Consequently, the initial observation on the FDA Form 483 was withdrawn. Ultimately, no significant deficiencies were upheld during this inspection, meaning no specific required corrective actions stemming from violations were mandated for Quotient Sciences-Miami, Inc.