FDA 483 - Massco Dental - September 02, 2022

Dunagin Pharmaceuticals, Inc. dba Massco Dental in Rogers, AR, was cited with seven observations during an FDA inspection. The firm demonstrated significant deficiencies across its manufacturing operations, including a lack of validation for its water system, manufacturing processes, and cleaning procedures. Additionally, the quality control unit was found to be inadequate, and there were issues with component testing, equipment maintenance, and laboratory investigations, indicating a systemic failure to ensure drug product quality and purity.