FDA WARNING_LETTER - Aire-Master of America, Inc. - October 19, 2021

The FDA issued a Warning Letter to Aire-Master of America, Inc. following an October 2021 inspection of their Nixa, Missouri drug manufacturing facility. The letter cited significant Current Good Manufacturing Practice (CGMP) violations (21 CFR parts 210 and 211), rendering drug products adulterated. The firm's response to the Form FDA 483 was deemed inadequate. CGMP violations included: failure to establish scientifically sound laboratory controls and specifications, particularly for water system monitoring and microbiological testing (21 CFR 211.160(b)); inadequate investigation of discrepancies, such as a "fishy" odor complaint in hand sanitizer (21 CFR 211.192); failure to conduct appropriate microbial testing for each drug product batch prior to release (21 CFR 211.165(b)); failure to adequately clean and maintain equipment, specifically using shared equipment for OTC drugs and industrial cleaners without validated cleaning methods (21 CFR 211.67(a)); and failure to conduct identity testing for drug product components, with insufficient methods for glycerin and ethyl alcohol to detect toxic contaminants (21 CFR 211.84(d)(1)). Furthermore, Aire-Master Foaming Hand Sanitizer products were deemed unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, and misbranded under section 502(ee) as they did not meet marketing requirements. The FDA strongly recommended a CGMP consultant. The firm must respond within 15 working days with corrective actions and a prevention plan, or face potential regulatory actions including seizure, injunction, and withholding of approvals or export certificates.