FDA 483 - Accurate RX Pharmacy Consulting LLC - July 15, 2021

An FDA inspection of Accurate Rx Pharmacy Consulting, LLC dba Diplomat Specialty Infusion Group, a sterile human drug producer in Columbia, MO, identified critical deficiencies in aseptic processing. Observations included the use of non-sterile cleaning agents and wipes in ISO 5 areas, the presence of difficult-to-clean equipment surfaces, and a failure to disinfect materials before their transfer into aseptic processing environments. These findings indicate a lack of adequate controls to prevent contamination during sterile drug production.