Stira Pharmaceuticals LLC – FDA EIR, Nov 5, 2021

An FDA surveillance inspection of Stira Pharmaceuticals LLC, a control testing laboratory located in Fairfield, NJ, was conducted from October 27 to November 5, 2021. This marked the firm's initial Good Manufacturing Practice (GMP) inspection, primarily focusing on its quality and laboratory control systems under compliance program 7356.002. The inspection led to one written observation on Form FDA 483. The main violation identified was the absence of appropriate controls over computer systems and related equipment, failing to ensure that changes to master production and control records or other critical data are performed only by authorized personnel. Specifically, raw data files on the 'C' drive of certain laboratory instruments could be deleted without being captured in the software's audit trail or the Windows event viewer, making such actions untraceable. Furthermore, the software for these critical analytical systems had not undergone formal validation or qualification to demonstrate that all critical events are reliably captured in their audit trails. This contravenes regulatory requirements outlined in 21 CFR 211.68(b) for computerized systems. Stira Pharmaceuticals' Chief Executive Officer, Dr. Satyanarayana Valiveti, acknowledged the observation and committed to implementing the necessary corrective actions and submitting a comprehensive response to the agency within 15 business days following the inspection.