Diaz Trade Consulting provides FDA compliance assistance for food, dietary supplements, and alcoholic beverages, over-the-counter drugs, cosmetic, and medical device companies. The purpose of compliance assistance is to ensure your product is marketable in the U.S., prior to importation to the U.S., to help prevent delays and inconvenient costs. We provide Claim and Labelling Review as well as VCRP Registration and Ingredient Statement filing services. Compliance services include product and label review, U.S. Agent services, and registration with the FDA for food, medical device, over the counter drug, and voluntary registration for cosmetic facilities.
One of the many requirements under FSMA is that importers must develop a Foreign Supplier Verification Program (FSVP) to provide adequate assurances that their foreign suppliers are producing compliant food. Importers covered by the FSVP regulation must put in place foreign supplier verification programs (FSVPs) to verify that their foreign suppliers are producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls (for human or animal food) or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling (21 CFR 1.502(a)).
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time
Background on Food Facility Registration
The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or