FDA 483 - Big Gain, Inc. - October 20, 2022

Big Gain, Inc. in Mankato, MN, was inspected regarding its animal food manufacturing operations. The inspection revealed a failure to identify and evaluate known or reasonably foreseeable hazards in its hazard analysis, specifically concerning ammonium chloride in goat feed and copper in sheep feed. This oversight led to animal illnesses and deaths, including goats suffering from urinary calculi and sheep at risk from excess copper.