AG/FDA Blog

FDA Announces FY 19 User Fee Rates for Third Party Certification Program

Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certif… Read More
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Intentional Adulteration Mitigation Strategies – Initial Draft Guidance

The FDA Food Safety Modernization Act contained provisions aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.  This was the first time tha… Read More
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Focus on Food Recalls

In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures.  Recall policies and procedures likely will be a focus of FDA in the coming year. The Office of Inspector General (OIG) within… Read More
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FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1]  The webpage includes deadlines for the following rules:… Read More
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FDA Inspector General Report on Progress of FSMA Inspections

On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on the agency’s domestic food facility inspections: Challenges Remain in FDA’s Inspections of Domestic Food Fac… Read More
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FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s c… Read More
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I’m a FSVP Importer: How Do I Know When I Need To Comply?

That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course.  Determining the compliance dates is typically more chal… Read More
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The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also… Read More
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FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulga… Read More
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FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Imp… Read More
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