SECTORS
FDA & USDA
Navigating US federal regulations (FDA & USDA) is non-negotiable for food manufacturers, importers, and processors. We ensure your operation is completely compliant with all necessary rules, from your foundational safety plan to your required licenses.
1. HACCP Plan Development and Optimization
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The Hazard Analysis and Critical Control Points (HACCP) system is the cornerstone of food safety mandated by both the FDA and USDA. We don't just create documents; we create working systems:
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Custom HACCP Creation: We develop comprehensive, scientifically sound HACCP plans tailored precisely to your specific products and processes, meeting either FDA (e.g., Juice, Seafood, FSMA) or USDA (Meat, Poultry) requirements.
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HACCP Updates & Changes: If your products, equipment, or regulations change, your HACCP plan must change with them. We manage all necessary reassessments and modifications to your existing plan to ensure it remains valid, defensible, and up-to-date.
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Preventive Controls (PCQI): We align your HACCP plan with the FDA's FSMA Preventive Controls for Human Food requirements, ensuring your system is compliant with modern regulatory expectations.
2. Regulatory Readiness and Licensing
Beyond the safety plan, we help you manage the essential administrative and regulatory requirements for operating in the US market:
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License and Registration Support: We guide you through the process of obtaining and maintaining all mandatory federal and state licenses, permits, and registrations, including FDA Facility Registration and USDA Grants of Inspection (GOI).
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Labeling Compliance: We review and verify your product labels meet the stringent requirements of the FDA and/or USDA for ingredients, nutrition facts, allergen declarations, and claims.
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Inspection Preparedness: We prepare your team for smooth and successful FDA/USDA inspections by conducting mock audits and ensuring all required records are organized and readily available