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 Inspection, Hazard Analysis and Food Safety Planning, and Food Defense Planning assistance for companies in the food, beverage, and dietary supplement industries.
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.
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.
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.
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.
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, include those subject to DWPE due to an FDA Import Alert.
State Bottled Water Requirements
Many U.S. states require licensing, certification, or additional labeling statements for bottled water sold in their jurisdiction in additon to FDA regulations. Registrar Corp offers reports that explain the different requirements for each state.