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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Should Your Establishment Appeal a FSIS Decision?

By Brett Schwemer, as published in The National Provisioner To appeal or not to appeal; that is the question Establishments regulated by the Food Safety and Inspection Service (FSIS) frequently face the dilemma on whether to appeal agency decisions t… 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 aware… Read More
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Data Driven Decision Making by Dr. Doom

When asked to visit an establishment to assess compliance, my first step is always to ask for data. Establishment food safety data, laboratory results, regulatory data, audits…. What story is being told? Is there a trend in the making? Upward trend… Read More
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FDA Issues Final Compliance Policy Guide on Food Facility Registration

The Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG) on food facility registration. Compliance Policy Guide Sec. 100.250; Food Facility Registration – Human and Animal Food. The CPG provides guidance to FDA staff… Read More
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Getting to the Roots of Listeria – A Practice Tip from Ms. Gloom

Dr. Doom discussed “getting to the roots” of issues to ensure the cause is eliminated in her recent article. This is the same approach that facilities need to use each and every time they have a positive finding of Listeria monocytogenes (Lm), or… Read More
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“Time”-ly Tip from Dr. Doom

There has been a great deal of noise in the media recently about “plants running without inspection” and the significance to both the establishment and to FSIS. It is important to remember that no operations requiring inspection shall be conducte… Read More
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