FDA has cited the defendants for numerous deviations from cGMP over the last five years. FDA inspected Milbank Mills four times during this period, and found gross deviations from cGMP that resulted in voluntary recalls of medicated animal feeds. Despite repeated warnings from FDA, the defendants have continued to manufacture medicated animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and its regulations.

Medicated animal feeds include specific types and amounts of drugs to prevent disease in food-producing animals, and failure to comply with cGMP requirements when manufacturing such feeds renders the product adulterated (or illegal). Among other cGMP violations, Milbank Mills repeatedly failed to store and handle drugs properly to maintain their effectiveness, did not maintain records of drug inventory and use, and did not adequately test its feed products to ensure that they contained the correct amounts of drugs. In addition, Milbank Mills did not accurately label its medicated feed products or provide adequate directions for their use.

Under the consent decree, failure to comply with the terms could result in civil or criminal penalties. Consumers who may have purchased adulterated feed from Milbank Mills should contact the company directly.