FDA 483 - Mericon Industries Inc. - March 14, 2025

An FDA inspection conducted from February 11-14, 2025, at Mericon Industries Inc., a drug manufacturer in Peoria, IL, revealed multiple significant deviations from regulatory expectations. The company received an FDA Form 483 outlining critical issues affecting drug product quality and control. Primary violations included inadequate testing of components, where raw materials were not consistently tested for identity or potential contaminants like diethylene glycol, and expired materials were used. Supplier qualification procedures were also deemed insufficient. The quality control unit demonstrated widespread failures, including releasing drug products without batch record approval and neglecting crucial stability testing. The company lacked essential, approved standard operating procedures for deviations, change control, supplier evaluation, investigations, and employee training. Annual product reviews were also not maintained. Furthermore, finished drug products, such as Hydrocortisone Lotion 1%, were distributed without laboratory verification of active ingredient content. Production processes, specifically bottle filling operations, were not adequately validated for manufacturing or cleaning. Batch production and control records were incomplete and inconsistent, showing discrepancies in equipment cleaning logs and missing data points crucial for tracking manufacturing operations. Mericon Industries Inc. is expected to promptly implement thorough corrective actions to resolve these deficiencies, ensuring full compliance with drug manufacturing regulations to guarantee product identity, strength, quality, and purity.