FDA EIR - Morton Salt Inc - May 23, 2025

A routine, unannounced cGMP inspection of Morton Salt Inc.'s Active Pharmaceutical Ingredient (API) manufacturing and repackaging facility in Rittman, OH, was conducted by the FDA from May 19 to May 23, 2025. This inspection, carried out under the regulatory framework of CP 7356.002F and PAC 56002F, resulted in the issuance of an FDA-483 due to several observed deficiencies.

The main violations identified were: failure to adequately investigate out-of-specification (OOS) results, deviations, and customer complaints, including the implementation of appropriate corrective actions and follow-up; failure to validate the suitability of analytical and equipment cleaning methods; and failure to maintain complete laboratory control records for test methods and OOS investigations.

During the inspection, previous concerns from a 2019 inspection regarding elemental impurities, data integrity, and metal detector implementation were verified as corrected. However, the new issues required immediate attention. Morton Salt Inc. committed to addressing all observations and providing a written response to the FDA within 15 business days. The inspection concluded with a "Voluntary Action Indicated" (VAI) classification, signifying that the firm must implement corrective actions to achieve compliance.