USFDA Consulting

USFDA Consulting

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.