US FDA Registration & FSMA Compliance
Selling food into the United States requires more than a great product. FoodX Solutions helps Malaysian and Singapore manufacturers navigate FDA facility registration, appoint a US Agent, review labelling and prepare for FSMA requirements — so shipments clear customs and stay compliant.
What we deliver
FDA facility registration
Initial registration and biennial renewal, with correct product category and DUNS setup.
US Agent coordination
Guidance on appointing a qualified US Agent as required for foreign facilities.
FSMA readiness
Assessment against Preventive Controls for Human Food (PCHF) and other FSMA rules relevant to your product.
Labelling & nutrition review
US-format nutrition facts, allergen declarations, ingredient statements and claims review.
Prior Notice guidance
Support on Prior Notice of Imported Foods to reduce risk of shipments being held.
Audit-ready documentation
Food safety plan, hazard analysis and preventive controls documentation aligned to US expectations.
Access the world's largest food market
Our FDA roadmap
Product and facility scoping.
US Agent coordination and registration.
FSMA gap analysis and food safety plan.
Labelling and Prior Notice review.
Ongoing renewal and update support.
Frequently asked questions
Talk to an FDA compliance consultant
Planning to export to the USA? Get a readiness check before your first shipment. WhatsApp +60 11-1066 9909 (MY) / +65 9642 4838 (SG).