FDA 483 - Custom RX LLC - August 15, 2017

An FDA inspection of Custom RX, LLC in Wichita, KS, revealed significant deficiencies in aseptic processing and facility cleaning. Observations included an operator spraying gloves over open sterile drug product vials and media fills not representative of production. Additionally, the firm failed to adequately clean the ISO 5 hood after smoke studies and used commercial dish soap for sterile glassware.