2018 FSMA inspections: Lessons learned

In 2018, the U.S. Food and Drug Administration (FDA) conducted 622 current good manufacturing practice inspections related to the Food Safety Modernization Act. Those inspections were conducted in 47 states, Puerto Rico and four foreign countries – Canada, India, Indonesia and Mexico – that do business in the U.S. and therefore must be in compliance with FSMA. Fifty-eight percent of the inspections took place at feed integrators, 11 percent at pet food facilities, 24 percent at ingredient/rendering facilities, 6 percent at warehouses and 1 percent at food/beverage facilities or other type of facility.Davis said that, as a result of these inspections, 28 Form 483s were issued. According to the FDA, “Form 483 is issued to management at the conclusion of an inspection when an investigator has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts.”