We are a trusted partner in navigating the complexities of FDA regulations and compliance. At FSW, we are dedicated to helping businesses achieve and maintain compliance with the U.S. Food and Drug Administration (FDA) standards, ensuring your products meet regulatory requirements and succeed in the marketplace.

We offer a wide range of consulting services to support your regulatory needs, including:

• USFDA Registration / Food Facility Registration: To successfully navigate FDA regulatory requirements, it is essential to create a new FDA Industry System (FIS) account, obtain a Unique Facility Identifier (DUNS number), and add a Food Facility Registration (FFR) to your FIS account. The process begins by establishing your FIS account, which serves as the primary platform for managing your regulatory submissions and communications with the FDA. Next, you must acquire a Unique Facility Identifier, commonly known as a DUNS number, which is necessary for identifying your business and facility within the global supply chain. Once these steps are completed, you should add your Food Facility Registration to the FIS account to ensure your facility is properly registered with the FDA, facilitating compliance with food safety regulations and streamlining your operations.
• Compliance Audits and Inspections: Conducting thorough internal audits and mock inspections to identify and address potential compliance issues before the FDA does.
• Quality Management Systems: Developing and implementing robust quality management systems to ensure ongoing compliance with FDA regulations. Food Safety Modernization Act (FSMA) is crucial for maintaining compliance and ensuring the safety of food products being exported to the US.
• PCQI and Regulatory Training: Providing specialized PCQI (Preventive Controls Qualified Individual) training to equip your team with the knowledge and skills necessary to comply with the Food Safety Modernization Act (FSMA) requirements. Regulatory training and workshops for your team to stay up-to-date with FDA requirements and best practices.
• Product and Label Review: Offering support with pre-market activities, like reviewing of Food Label as per F.D.A Standards.

FSMA Certification

The Food Safety Modernization Act (FSMA) is a law which was drafted in the USA with the objective of reducing foodborne illnesses and deaths in USA. The FSMA was enacted in January 2011 and it was the first major reform of the food safety provisions to the Food, Drug & Cosmetic Act (FD&C Act) in over 70 years. FSMA provides the FDA a legislative mandate to require comprehensive, preventive control standards across the food supply chain, including those for the safe production, harvesting, packing and storage of raw agricultural commodities including agricultural produce. The addition of Hazard Analysis Risk based Preventive control (HARPC) along with Hazard Analysis Critical Control Point (HACCP) further improves the robustness of the food safety plans of the stakeholders.

The major changes brought in by the FSMA are with respect to the addition of preventive controls for food for humans and preventive control for food for animals, accredited third party certification, foreign supplier verification program (FSVP), produce safety, transportation and food defense.

FSMA also provides the FDA with a legislative mandate to require comprehensive, science based preventive controls across the food supply chain. The FSMA mandates the FDA to have an inspection frequency. It also empowers the FDA to ask for documents related to employee training, sanitation records and other documents including the food safety plan during audits.

Further, under the preventive control for food for humans, minimum safety standards for manufacturing, processing, packaging, and holding human food, employee training requirements, Good Manufacturing Practices (GMPs) & HARPC.

FSMA was passed 2011 to address the fact that there are over 48 million illnesses per year in USA caused by food that could have been prevented with better manufacturing, packaging, distribution and holding practices across the food chain. Since food safety is the responsibility of all the stakeholders involved in the food chain, FSMA provides a comprehensive approach towards tackling the modern aspects of food safety.

Who does FSMA apply to?

The rules under FSMA applies to all businesses reporting under the FDA. It applies to all the domestic and foreign firms producing food for consumption in USA. All producers, including manufacturers, processors, packers and distributors must comply with the FSMA regulations. Importers importing food into USA are also required to comply with the rules under FSMA.