FDA 483 - Aire-Master of America Inc - October 19, 2021

The FDA issued a Form 483 to Aire-Master of America Inc. in Nixa, MO, following an inspection that revealed nine significant observations, including repeat findings. The deficiencies primarily concern the firm's quality control, production, and laboratory systems, highlighting a lack of written procedures, inadequate investigations, and insufficient testing of raw materials and finished drug products, particularly hand sanitizers. These issues indicate a failure to ensure the identity, strength, quality, and purity of drug products manufactured at the facility.