FDA 483 - RXQ Compounding LLC - June 06, 2019

RXQ Compounding LLC, an Athens, OH 503B Outsourcing Facility, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical issues across sterile compounding, quality control, environmental monitoring, equipment cleaning, personnel training, and laboratory controls. These findings indicate a severe lack of adherence to good manufacturing practices, potentially compromising the safety and quality of their drug products.