FSMA Consulting

What Is FSMA?

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 and is the most comprehensive reform of US food safety laws in over 70 years. The Act aims to ensure the safety of the US food supply by shifting the focus from responding to contamination to preventing it. It also takes into consideration animal food and feed. The Act is comprised of seven main tenets:

  • Sanitary Transport of Human and Animal Food or the “Sanitary Transport Rule”
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food or the “PCHF Rule”
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Animal Food or the “PCAF Rule”
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption or the “Produce Rule”
  • Mitigation Strategies to Protect Food Against Intentional Adulteration or the “IA Rule”
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, known as “FSVP”
  • Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications

With a few exceptions, companies required to register with the FDA must follow each of the applicable rules for the safe manufacturing, processing, packing and holding of food intended for human or animal consumption.

Why Is FSMA Consulting Important?

Avert has over 20 years of experience working with the FDA on behalf of dietary supplement and food manufacturers. Our experienced advisors evaluate your business to ensure your compliance with the applicable tenets of the Act. From creation of food safety plans and development of preventive controls to vulnerability assessments under the IA Rule, Avert is your go-to resource.

The FDA periodically inspects each US registered facility for compliance with FSMA. Facilities failing to comply can experience fines, recalls, or ultimately be shuttered for non-compliances. Whether you’re a startup in need of food safety plan creation or an existing company looking to ensure or enhance compliance, Avert can help. We have lead instructors for the various rules of FSMA on staff so we’re uniquely positioned to create robust yet lean systems for all your FDA compliance needs.

Commercial Manufacturing

Let's Talk About It!

You never know when the FDA might knock at your door. If your systems are proven and verified it can be a painless exercise. Don’t let food safety regulations have a negative impact on your business. With the FDA’s increased powers under the Act, such as the ability to initiate recalls, smart companies put the necessary time and energy into proactively complying with FSMA. Call or email us today!

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