FDA 483 - ABC Compounding Co., Inc. - April 21, 2023

ABC Compounding Co., Inc. in Conyers, GA, an OTC drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. Key issues include releasing drug products that failed microbial specifications after repeated retesting, inadequate reprocessing procedures, and a lack of proper laboratory controls for raw material testing and supplier qualification. The firm also failed to validate its water system, establish expiration dates, maintain written quality control procedures, and implement a robust stability program.