“The U.S. Food and Drug Administration (FDA) has increased the number of routine inspections of all food facilities to meet new requirements mandated by the FDA Food Safety Modernization Act (FSMA), which was signed into law by the President on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
Under FSMA, FDA will continue its practice of selecting facilities for inspection based on risk. FSMA required FDA to immediately increase inspections of both foreign and domestic food facilities, including manufacturers/processors, packers, repackers, and holders of foods under FDA jurisdiction, and mandated an inspection frequency, based on risk, for food facilities. All high-risk domestic facilities must be inspected within five years of enactment and at least once every three years after that. Within one year of enactment, the law directed FDA to inspect at least 600 foreign facilities and to double those inspections every year for the next five years.
FDA’s foreign surveillance inspections are designed to identify potential food safety problems before products arrive in the United States, to determine the compliance status of facilities with FDA’s requirements and food safety standards, to help the agency make admissibility decisions when food products are offered for importation into the United States, and to help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.
These routine inspections are not conducted as part of a public health emergency, but are an important way for FDA to ensure that foreign food facilities exporting to the U.S., and their products, meet U.S. requirements. It is important to note that routine inspections are designed to evaluate a facility’s adherence to applicable U.S. laws and are not designed to assess a Competent Authority’s food safety system. As such, these inspections are different from systems audits.”