FDA WARNING_LETTER - HTO Nevada, Inc. dba Kirkman - August 22, 2025

The FDA issued a Warning Letter to HTO Nevada, Inc. dba Kirkman following an inspection of their Lake Oswego facility from August 18 to 22, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, classifying their drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations included the quality control unit"s failure to adequately oversee drug manufacturing operations. Specifically, the firm released reformulated over-the-counter drug products with inaccurate labeling, failing to list the new active pharmaceutical ingredient. There was also insufficient oversight of contract testing laboratories and a lack of annual product reviews. Additionally, the company failed to establish adequate written procedures for production and process control, evidenced by a lack of process validation data and an unqualified water system used in drug production. The FDA also noted a failure to establish and follow an adequate written testing program to assess drug product stability, meaning there was no scientific evidence to support labeled expiry periods. These issues were exacerbated by similar observations noted in a previous inspection in 2019. Despite the firm"s stated intent to cease drug production, their initial response was deemed inadequate, particularly regarding corrective actions for distributed products. The FDA requires HTO Nevada to provide comprehensive risk assessments, develop corrective and preventive action plans, and potentially engage a CGMP consultant to ensure compliance and address product safety on the market. The company must also clarify its long-term manufacturing intentions.