“FDA’s selection of foreign food facilities for inspection is based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include the following: (1) the food safety risk associated with the commodity (the type of food), (2) the manufacturing process, and (3) the compliance history of the facility, such as refusal rates for products that were denied entry into the United States. In addition, section 201 of FSMA requires FDA to identify high-risk facilities and allocate resources to inspect facilities according to the known safety risks, and includes several other factors to consider when developing a facility’s risk profile.
As stated above, the food safety risk associated with the commodity is a primary factor contributing to a facility’s risk profile. High risk food commodities include, but are not limited to, modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products; unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods. This list is not exhaustive. FDA may conduct routine inspections of other food commodities as part of its surveillance activities.
Please visit the FSMA Domestic Facility website for information on how FDA currently identifies a high risk food facility in the domestic arena. FDA is working on a similar risk categorization scheme, as developed for the selection of domestic facilities, to further describe the selection of foreign food facilities for inspection.”