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Registration
and U.S. Agent
FDA registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States by humans or animals. Companies located outside the United States must designate a U.S. Agent for FDA communications.
The Food Safety Modernization Act (FSMA) changed FDA food safety regulations. Registrar Corp provides assistance to the food, beverage, and dietary supplement industries to achieve FDA compliance by developing Food Safety Plans, HACCP Plans, Food Defense Plans, FSVPs for importers, and more. We can also help you prepare for an FDA inspection.
Food Safety
and FSMA
Labeling and
Ingredient Review
Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify their food, beverage, or dietary supplement labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents.
Prior Notice is required before food shipments may enter the United States. A bar-coded Prior Notice Confirmation Number issued by FDA must accompany most shipments.
Prior
Notice
FCE-SID Requirements for LACF Foods
Food Canning Establishment (FCE) registration and scheduled process filings (SIDs) are required for certain low-acid canned and acidified foods that may be consumed in the United States.
Export Certificates and Listing for U.S. Exporters
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. U.S. exporters must also be on an FDA export list in order to ship dairy, infant formula, collagen, gelatin, or seafood products to certain countries.
GACC Registration
China’s General Administration of Customs (GACC) requires registration of facilities manufacturing or processing food products exported to China. Registrar Corp can help properly submit your GACC Registration to China.
Color Additive Regulations
A food color additive is any dye, pigment, or other substance that can impart color to a food product. Food color additives are regulated by FDA.
Detention Assistance
With the exception of most meat and poultry, food, beverages, and dietary supplements, are subject to examination by FDA when imported into the United States. Registrar Corp provides immediate assistance for companies with products detained at the port of entry by FDA, including those subject to DWPE due to an FDA Import Alert.
Food Contact Substance Regulations
Anything that touches food (or touches something that touches food) may be considered an Indirect Food Additive. FDA regulations regarding the use of indirect food additives are known as “Food Contact Substance” regulations.
