FDA EIR - Kashiv BioSciences, LLC - February 09, 2015

Therapeutic Proteins International, LLC, a pharmaceutical manufacturer, was inspected by the FDA from January 13 to February 9, 2015. This data integrity audit, conducted under various drug manufacturing compliance programs, was the firm's first inspection. The inspection revealed significant Current Good Manufacturing Practice (cGMP) deficiencies, resulting in a 4-point FDA-483. Key violations included a failure to consistently conduct documented investigations into complaints regarding data integrity and manufacturing issues, notably concerning a failed clinical study. The firm's Quality Unit was found to be ineffective in monitoring quality systems, lacking clear policies for notifying top management of critical issues, and an adequate system for managing and investigating failures, deviations, and corrective and preventive actions (CAPAs). Additionally, the Quality Unit did not maintain proper control over raw data forms. The company also lacked appropriate controls to ensure properly validated test methods were utilized for clinical studies, which led to inaccurate product concentration and potency measurements. Lastly, the system for performing and managing Out of Specification (OOS) investigations was deemed ineffective, exhibiting deficiencies in contemporaneous documentation and control. The company's Chairman and CEO acknowledged the observations and committed to implementing corrections and providing a written response to the FDA within 15 days.