The US Food and Drug Administration has prohibited Milbank Mills, an animal feed mill in Chillicothe, Missouri, from manufacturing, processing, or distributing medicated animal feed.
Milbank Mills and its officers face these restrictions until they comply with
current Good Manufacturing Practice (cGMP) requirements for medicated animal
feeds.
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.
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.