U.S. Food and Drug Administration (FDA) and Food Safety and Inspection Service (FSIS) U.S. Department of Agriculture.

According to the United States Food and Drug Administration (U.S. FDA), the United States Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC), an estimated 48 million people in the U.S, implying 1 in every 6 persons get sick, 128, 000 are hospitalized, while about 3,000 lose their lives yearly due to preventable food-borne disease. This implies that improper food safety and quality measures in food SMEs are a significant public health burden in the U.S. and the world at large.

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 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 inspections, ensuring your facility complies with cGMP (current Good Manufacturing Practices) and every needed regulatory requirement of the FDA and USDA.

FDA and USDA Submission Support: We offer support in preparing and submitting various FDA and USDA 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 requirements.

Benefits of Our FDA and USDA Compliance and Consultation Service:

Regulatory Compliance

Our services help you meet FDA and USDA requirements and reduce the risk of legal issues, hefty fines, or business closure.

Product Safety

Compliance with FDA and USDA 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 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 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 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 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.