FDA 483 - Sanitizer Supply LLC - March 31, 2022

An FDA inspection of Sanitizer Supply LLC in Suwanee, GA, an OTC manufacturer of hand sanitizers, revealed significant deficiencies across its quality system. The firm lacked an effective quality control unit, failed to maintain complete batch production records, and did not establish adequate laboratory controls or stability data for its drug products. These widespread issues indicate a severe lack of adherence to current Good Manufacturing Practices.