FDA 483 - Mana Products, Inc. - September 25, 2025

Mana Products, Inc., an OTC drug manufacturer in Long Island City, NY, was cited for significant deficiencies in laboratory controls, quality control unit review of production records, and instrument calibration. The inspection revealed issues including unauthorized product specification changes, failure to investigate water system microbial contamination, and overdue calibration of critical monitoring equipment. These observations indicate a lack of adherence to established procedures and regulatory requirements for ensuring product quality and purity.