FDA 483 - Mana Products, Inc. - October 17, 2022

Mana Products, Inc., an OTC and cosmetic manufacturer in Long Island City, NY, was cited for three significant violations during an FDA inspection. The firm failed to adequately investigate unexplained discrepancies and implement corrective actions. Additionally, critical laboratory instruments were not calibrated at suitable intervals, and the quality control unit did not fully follow procedures for storing retain samples and initiating stability studies.