FDA 483 - RC Outsourcing, LLC - September 23, 2022

RC Outsourcing LLC, an outsourcing facility in Lowellville, OH, was inspected regarding its sterile drug repackaging operations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control unit responsibilities, and equipment calibration. Additionally, the firm failed to submit adverse event reports to the FDA in a timely manner.