FDA 483 - Morton Salt, Inc. - November 06, 2025

An FDA inspection at Morton Salt, Inc.'s drug substance manufacturing facility in South Hutchinson, KS, conducted from November 3-6, 2025, revealed significant non-compliance with Current Good Manufacturing Practices. Key violations included the failure to maintain facility buildings in a clean condition, with recurring process deviations and potential contamination risks from damaged equipment insulation and rusted components, without adequate investigation or corrective actions. The firm also released raw materials for manufacturing without performing required identity testing, leading to the distribution of untested product lots. Furthermore, production operations failed to prevent contamination, evidenced by insufficient investigation of foreign material findings, unpreserved metal detector alarm logs, and inconsistent documentation of in-process quality tests. Analytical test procedures lacked proper validation, and out-of-specification results were not thoroughly investigated. Customer complaints were not comprehensively recorded or investigated, and crucial stability testing on Active Pharmaceutical Ingredient (API) batches was either absent or insufficiently sampled for significant production periods. Morton Salt, Inc. must address these systemic deficiencies to ensure product quality and regulatory compliance.