U.S. Food Industry Regulation Compliance Consultation Service
According to the United States Food and Drug Administration (U.S. FDA), the United States Department of Agriculture – Food Safety Inspection Services (USDA-FSIS), and the Centers for Disease Control and Prevention (CDC), an estimated 48 million people in the United States, that is, one (1) in every six (6) persons get sick, 128, 000 are hospitalised, while about 3,000 lose their lives yearly due to preventable food-borne disease. This implies that improper food safety and quality measures in United States food SMEs are a significant public health burden in the United States of America (USA).
Key Benefits
Market Access
Product Safety
Enhanced Brand Reputation
Regulatory Compliance
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In 2011, the Food Safety Modernization Act (FSMA) was signed into law, under FDA jurisdiction, with the primary goal of proactively preventing foodborne illnesses to protect public health. FSMA regulations apply to food businesses, both domestically and abroad. These rules include Preventive Controls for Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Programs (FSVP) rule.
Our dedicated team of industry consultants specializes in comprehensive FDA compliance, quality systems, and GMP matters (Good Manufacturing Practice Regulations). We work closely with your management team, ensuring that every step, from the initial gap analysis to quality control system enhancement and implementation, is executed flawlessly.
As a provider of regulatory compliance solutions, we cater to food enterprises regulated by the U.S. FDA and USDA. Our seasoned consultants offer expert guidance to meet your specific regulatory needs. Whether you’re a small-scale food business or a large food manufacturer, we provide support across a spectrum of food safety compliance challenges.
We extend our assistance to food manufacturers in crucial areas such as food safety, food defense, food labeling, food process operations, food formulations, and packaging programs. Our services are designed to align with the rigorous requirements of the U.S. FDA and USDA, while meticulously assessing and mitigating regulatory noncompliance risks.
Our FDA and USDA Compliance and Consultation Services:
Regulatory Guidance: We provide expert guidance on FDA and USDA-FSIS regulations, helping you understand the specific requirements that apply to your food products.
Labeling Compliance: Our experts review and ensure that your product labels accurately meet and comply with the FDA standards and requirements, including nutritional information, health claims, and allergen declarations.
Facility Inspections: We assist in preparing for and responding to FDA and USDA-FSIS inspections, ensuring your facility complies with cGMP (current Good Manufacturing Practices) and every needed regulatory requirement of the FDA and USDA-FSIS.
FDA and USDA-FSIS Submission Support: We offer support in preparing and submitting various FDA and USDA-FSIS applications, such as GRAS (Generally Recognized as Safe) notifications, food facility registrations, and new dietary ingredient notifications (NDINs).
Risk Assessment: We help your food enterprise in assessing and mitigating potential risks associated with your products to ensure their safety and compliance with FDA and USDA-FSIS requirements.
Benefits of Our FDA and USDA-FSIS Compliance and Consultation Service:
Regulatory Compliance
Our services help you meet FDA and USDA-FSIS requirements and reduce the risk of legal issues, hefty fines, or business closure.
Product Safety
Compliance with FDA and USDA-FSIS regulations is the cornerstone of product safety, ensuring the well-being of consumers in the U.S.
Market Access
Complying with FDA and/or USDA-FSIS requirements allows you to access the U.S. market and reach a broader customer base which results in a revenue boost for your food business.
Enhanced Brand Reputation
Demonstrating a commitment to FDA and/or USDA-FSIS compliance builds trust with consumers and regulators, strengthening your brand reputation and market success, with a resultant boost in sales and revenues for your food enterprise.
Get In Touch
Fresh Group is dedicated to helping you navigate the complexities of FDA and USDA-FSIS regulations and ensuring that your food products meet the highest standards of safety and quality.
Contact us today to discuss how our FDA and USDA-FSIS Compliance and consultation services can be tailored to meet your specific needs and provide you with the expertise required for success in the U.S. food market.