FSMA Food Safety Plans Development Support Service

Your Compliance Partner for the U.S. Market

Complying with the U.S. Food and Drug Administration (FDA)’s regulations can be complex, especially for Food & Beverage SMEs and international exporters. At Fresh Group – Food Safety and Quality Consulting, we specialize in developing Food Safety Modernization Act (FSMA)-compliant Food Safety Plans that help businesses meet regulatory requirements and ensure product safety in the U.S. market.

Whether you’re a food company in the United States or an importer of food, beverage, ingredients and raw materials into the U.S., our expert food scientist and food safety consultant is here to guide you every step of the way, ensuring full compliance with the FDA’s Food Safety Modernization Act.

Why FSMA Compliance is Mandatory for Food Business Importing, Manufacturing, Producing Distributing, Retailing in the United States

Since the 4th of January 2011, the Food Safety Modernization Act (FSMA) has been established to shift the focus of food safety from a reactive approach to preventive measures. The compliance with FSMA is mandatory for most food and beverage businesses, including food manufacturers, food importers, distributors, and retailers operating in the United States.

Failure to comply with the food safety mandates of the FDA’s FSMA can lead to serious consequences, such as official warnings, enforced product recalls, facility closure, import detentions, and legal action.

At Fresh Group, our FSMA Food Safety Plans are designed to help your business:

Comply with FSMA requirements,
Avoid costly disruptions and regulatory penalties,
Ensure consumer trust and brand reputation,
Secure smooth business operations in the United States food industry,
Enhance food safety and quality management systems.

Our FSMA Food Safety Plan Services

We provide customized FSMA Food Safety Plans tailored to meet the specific needs of U.S. food & beverage SMEs and international exporters targeting the U.S. market.

Our services include:

1.

Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans and Implementation

• In accordance with FSMA Section 103 / FD&C Act Section 418, implemented through 21 CFR Part 117 and upon your request, we will assist your company or food facility in writing and implementing a comprehensive food safety plan and preventive controls system to identify and manage all food safety hazards in your food production process and supply chain.,
• Our expert will help you implement science-based preventive controls to effectively mitigate all food safety risks, including physical, biological, allergenic, and radiological hazards, and put in place all necessary scientific and technical preventive controls under the Hazard Analysis and Risk-Based Preventive Control (HARPC) framework, necessary to ensure regulatory compliance and protect consumer health.

2.

Preventive Control Plans (PCPs) for Foreign Suppliers

• We support the United States food business that imports food, beverages, ingredients, and other raw materials to comply with the mandates of the foreign supplier verification program (FSVP). FSVP requires U.S. importers to verify that foreign suppliers produce food in compliance with U.S. safety standards. (Legal basis: FSMA Section 301, which created FD&C Act Section 805, implemented in 21 CFR Part 1 Subpart L (§1.500–1.514).
• With our expert guidance, you can confidently navigate the complexities of FSVP and ensure a smooth compliance of your imported food products into the United States.

3.

Intentional Adulteration (Food Defense)

• In accordance with the mandates of 21 CFR Part 121, we would help your food facility develop science-based mitigation strategies, implement a Food Defense plan, conduct vulnerability assessments, identify actionable process steps, and establish mitigation strategies in protecting your food facility's food supply from deliberate contamination intended to cause widespread public health harm.

4.

Recall and Traceability Programs

• We assist your food business in preparing for potential food safety incidents by developing comprehensive recall strategies that align with FDA and USDA-FSIS regulatory requirements, safeguarding both public health and your brand reputation.
• Our services include the implementation of robust traceability systems, enabling rapid, accurate responses to safety events. These systems help minimize risk, ensure consumer protection, and maintain full regulatory compliance.

5.

Employee Training and Compliance Support

• We offer FSMA training programs tailored for food handlers, supervisors, and compliance officers working for your company, ensuring your team understands current regulations and how to maintain ongoing compliance.
• In addition, we provide ongoing consultation services to help your business stay FSMA-compliant, keeping your operations aligned with evolving regulatory requirements and industry best practices.

Who Needs an FSMA Food Safety Plan?

You may be required to comply with the FDA’s FSMA mandates if your business operates in any of the following categories:

Food manufacturers and processors (g., bakeries, beverage producers, packaged foods).
Packers (those repacking bulk foods into consumer-ready packages).
Holders / storage facilities (warehouses, cold storage).
Animal food facilities (pet food, livestock feed producers).
Dietary supplement manufacturers (vitamins, nutraceuticals).
Facilities importing food into the U.S. (subject to HARPC if also processing/handling).
U.S. importers of human food.
U.S. importers of animal food.
Third-party importers acting on behalf of a U.S. company.
Importers of dietary supplements
Large commercial farms producing fresh produce.
Greenhouses and hydroponic operations producing raw produce.
Farm operations selling produce for human consumption.
Shippers (who own the food being transported).
Receivers (who take delivery of food).
Transporters (including carriers, refrigerated trucks, trucks, rail, or air cargo handling perishable foods).
Large-scale food manufacturers.
Processors of ready-to-eat foods.
Packaged foods with high-volume production.
Foreign food facilities exporting to the U.S. that are subject to FDA certification for food safety compliance.

Why Choose Fresh Group?

Industry Expertise

Our food safety professionals are Preventive Controls Qualified Individuals (PCQI) mandated by the U.S. Federal law, bringing deep expertise in FSMA and USDA-FSIS regulations, ensuring your business receives accurate, up-to-date, and reliable compliance guidance (Legal basis: FD&C Act Section 418, 21 CFR §117.126(c) and §117.180).

Customized Solutions

We develop FSMA complaint Food Safety Plans tailored specifically to your food business operations, therefore, ensuring practical and effective solutions that meets your unique business functions.

Global Reach

We support both U.S.-based companies, U.S. importers and international exporters in achieving and maintaining full regulatory FSMA compliance in the U.S. food market.

End-to-End Support

From food safety plan development to audit preparation, we provide expert guidance at every stage of your compliance.

Cost-Effective Compliance

Avoid warnings and notices from the U.S. FDA, costly fines and operational delays with our affordable, expert-led compliance solutions designed to deliver maximum value to your company, allowing you to focus on running your food business smoothy and upscaling your bottom lines.

Get Started Today

Ensure your food business is fully FSMA compliant and protect your brand, products, and consumers. Partner with Fresh Group – Food Safety and Quality Consulting for expert guidance, tailored solutions, and peace of mind in the U.S. food market.