Free FDA Compliance Readiness Checker
Find out in about two minutes whether your facility is ready to sell food, dietary supplements, cosmetics or OTC drugs in the United States. Answer seven quick questions on FDA food facility registration, U.S. Agent, labeling and more to get a readiness score and a list of gaps to close.
What the checker covers
Food & beverage. Food facility registration and the Oct 1 – Dec 31, 2026 renewal, U.S. Agent designation for foreign facilities, Prior Notice for shipments, U.S. labeling including allergens, and food safety plans under FSMA.
Dietary supplements. Food facility registration and renewal, U.S. Agent, 21 CFR Part 111 manufacturing practices, structure/function claims and notifications, and Supplement Facts labeling.
Cosmetics & personal care. Cosmetic versus drug claims, whether MoCRA facility registration and product listing apply to you, adverse event records, cosmetic labeling and safety substantiation records.
OTC drugs. Drug establishment registration and annual renewal, U.S. Agent, product listing with NDC numbers, OTC monograph conformity and drug GMPs.
Frequently asked questions
Is the checker free? Yes. The check is free and has no obligation. You see your score and gap list right away.
How long does it take? About two minutes. Every path has seven questions.
What happens to my answers? Your score and gaps show on screen. If you ask for a roadmap, your name, email, company and answers go to Axentra so a specialist can prepare your next steps and follow up.
Is my result an FDA determination? No. The checker is general information, not legal advice or an FDA decision. Axentra is independent and is not affiliated with or endorsed by the U.S. FDA.
Do cosmetics need a U.S. Agent? MoCRA does not require a U.S. Agent for cosmetic facilities. Food, dietary supplement and drug facilities located outside the U.S. must designate one.
General information only, not legal advice. FDA requirements depend on your specific products, claims and operations. Axentra Global Pharma Compliance LLC is an independent regulatory consultancy and is not affiliated with, or endorsed by, the U.S. FDA. Registration with FDA does not mean FDA approval.
Axentra Global Pharma Compliance LLC, 1209 Mountain Road Pl NE, STE 7912, Albuquerque, NM 87110.