Dixon Investments Inc – FDA Warning Letter, Mar 11, 2025

The FDA issued a Warning Letter to Dixon Investments Inc. dba ARI following an inspection from March 5 to 11, 2025. This letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, leading to their drug products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act. Furthermore, specific products were identified as unapproved new drugs and misbranded.

Key violations include a repeat failure to establish adequate written procedures for production and process control, notably lacking process validation for their over-the-counter (OTC) aerosol drug products. The company"s response regarding this was deemed inadequate due to missing specific timelines. A second repeat violation involved the firm"s failure to implement an adequate written testing program to assess drug product stability, leaving existing expiry dates unsupported by scientific evidence. Additionally, the quality control unit failed to adequately fulfill its responsibilities, showing deficiencies in areas like change controls, batch record release, corrective and preventive actions (CAPA), and equipment maintenance.

To address these issues, the FDA requires Dixon Investments to provide a detailed summary of its validation program, including timelines for process performance qualification for each marketed drug product. They must also submit a comprehensive, independent assessment and CAPA plan for their stability program. The company is also mandated to improve its deficient quality systems by enhancing procedures and oversight to ensure full compliance with CGMP regulations.