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HTO Nevada, Inc. dba Kirkman, an over-the-counter drug manufacturer, failed to maintain Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals, resulting in adulterated drug products. During an August 2025 inspection, the FDA identified critical failures in the quality control unit's oversight, including inadequate change control procedures that allowed reformulated drug products to be released and distributed with inaccurate labeling after API substitution. The company's September 2025 response was deemed inadequate because it only stated the firm would cease drug manufacturing without providing corrective and preventive actions or committing to market removal of affected products.