Food Canning Establishment (FCE) Registration, Scheduled Process Filings (SIDs)
Foreign canning establishments of low acid or acidified canned foods must register with FDA the specific facilities that process and cook canned foods for US consumption and they must describe the products and the processing undertaken at each facility. This FCE registration is in addition to the Bioterrorism Act food establishment registration requirement. When a food canning establishment registers with FDA it receives an FCE number. That FCE number then is used to file its scheduled processes of all the canned products manufactured at the facility for US consumption. The verified cook details (time/temperature/kill rate) of the scheduled process must be described to FDA in the filing along with supporting documentation. After FDA reviews the scheduled processes and supporting data, the agency issues SID numbers that are unique and specific to the product and the packaging size (can or pouch size). FDA usually requests the FCE and SID information for shipments of canned food at the time of entry.
In many cases, if FDA does not receive the FCE and SID information when the canned food is declared to Customs FDA will (essentially) automatically detain and possibly refuse admission to the shipment. If the manufacturing facility has registered and filed its scheduled process, FDAImports.com may be able to convince FDA to rescind the FDA refusal.
FDAImports.com affiliated attorneys have occasionally managed to obtain rescissions of FDA refusals on this basis. Our regulatory consultants and affiliated attorneys can also assist in the registration and filing processes to ensure products can be imported into the U.S.
FDAImports.com consultants and affiliated attorneys regularly assist clients in fulfilling their registration, listing, and scheduled process filing requirements. Additionally, FDAImports.com assists clients who find their products delayed, detained, or refused at the U.S. border due to frequent errors in governmental data systems.
