FDA EIR - Morton Salt Inc - January 10, 2019

A routine Good Manufacturing Practice (GMP) inspection of Morton Salt Inc.'s Rittman, OH facility was conducted by the FDA from January 8-10, 2019. The inspection focused on the company's active pharmaceutical ingredient (API) operations, specifically the manufacturing of Sodium Chloride USP, adhering to API Process Inspection guidelines. While no formal written observations were issued, the inspection identified several areas for improvement that were formally discussed with management. Key concerns included the inadequacy of the elemental impurities testing method used by a contract laboratory for solid salt samples, highlighting the absence of a formal quality agreement with that lab. Additionally, the inspection noted that data integrity checks on endotoxin testing could be made more robust. A significant concern was the delayed implementation of a metal detector on a specific production line, despite evidence that non-magnetic metal particulate could still contaminate finished product, necessitating its prompt installation. Morton Salt Inc. management was cooperative throughout the inspection, committing to expedient corrective actions for all identified concerns, with some initiatives already underway prior to the inspection's conclusion.