Pharmaneek Inc – FDA 483, Apr 8, 2026

Between March 30 and April 8, 2026, the FDA conducted an inspection of Pharmaneek Inc., a producer of non-sterile drug products located in Indianapolis, Indiana. The resulting Form 483 report outlines three primary areas of concern regarding product safety and quality control. First, the facility failed to implement adequate cleaning and containment procedures for hazardous drugs, specifically the oral suspension Hydroxyurea. Investigators noted a lack of deactivating agents and the improper storage of hazardous drug utensils alongside non-hazardous equipment, posing a significant risk of cross-contamination. Second, Pharmaneek Inc. failed to verify that the water used in its drug production met required quality specifications, despite using it as a primary ingredient in multiple lots. Finally, the inspection identified poor facility maintenance, including a damaged ceiling tile in the production room that exposed the area to environmental contaminants. These observations were made under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the FDA has not yet reached a final determination, the company is expected to respond promptly. Pharmaneek Inc. must provide a written response to the Detroit District Office detailing their completed or planned corrective actions to address these sanitary and procedural deficiencies.