I3CGLOBAL Group help food, alcohol, dietary supplement, cosmetic, and medical device companies comply with FDA requirements and regulations. The main purposes of "pre-compliance" assistance are to ensure that your product is marketable in the United States, before entry, and to avoid timely and costly delays.

Pre-compliance assistance includes product and label review, US agent services for the registration of foreign food facilities with the FDA, and potential registrations with the FDA 510k submission.

Examples of FDA enforcement actions may include Notices of Action (detention and/or seizure of merchandise), placement on the Import Alert ("red light") list, warning letters, merchandise inspections, and claims of liquidated damages issued by US Customs and Border Protection ("CBP") for violation of an FDA requirement or regulation.

We offer a full menu of FDA services tailored to companies both domestic and foreign. Assistance includes prior compliance (i.e., about bringing products to the US market) as well as assistance in successfully navigating FDA enforcement actions.

For more information about our FDA services, please visit our FDA Registration Page