FDA WARNING_LETTER - Imu-Tek Animal Health, Incorporated - October 14, 2025

Imu-Tek Animal Health, Incorporated, located in Fort Collins, Colorado, received a formal warning from the FDA following an inspection conducted between October 6 and October 14, 2025. The agency identified several significant violations of the Federal Food, Drug, and Cosmetic Act regarding the company’s Colostrom-5 capsules and powder products. The primary issue involves the marketing of these products; the FDA found that the company’s website made medical claims—such as the ability to kill viruses and treat bowel dysfunction—which classifies them as unapproved new drugs. Because these products are marketed for conditions requiring professional medical supervision, they also lack adequate directions for safe consumer use, resulting in a misbranding violation. Furthermore, the inspection revealed serious failures in manufacturing standards. Specifically, Imu-Tek failed to follow proper pasteurization procedures and did not establish necessary quality specifications for raw materials or finished goods. The company also lacked required master manufacturing records and detailed batch production records necessary to ensure product consistency and safety. While the company provided an initial response in October 2025, the FDA deemed the corrective actions insufficient. Imu-Tek is required to notify the FDA within 15 working days of the specific steps taken to resolve these issues and prevent their recurrence. Failure to comply may lead to legal action, including product seizures or injunctions.