Tag Archives: FSMA; FDA

FDA Issues Proposed Rule to Implement a Laboratory Accreditation Program for Food Testing as Required by FSMA

The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet. On November 1, 2019, FDA released a proposed rule under which FDA … Continue Reading

FDA Releases Fiscal Year 2020 Fee Rates and Reconfirms Policy of Not Invoicing for FSMA Food Facility Reinspection, Recall, and Importer Reinspection Fees

The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply … Continue Reading

Latest FDA Data Show Foodborne Pathogens in Fresh Herbs, Guacamole, and Processed Avocado; The Source of a New Multistate E. coli O103 Outbreak Remains a Mystery

  In 2014, the Food and Drug Administration (FDA) began random sampling and testing of a variety of commodities from domestic and foreign sources to learn more about the prevalence of disease-causing bacteria.  The first commodities sampled were sprouts, whole fresh avocados, and raw milk cheese (aged 60 days), followed by cucumbers and hot peppers.  … Continue Reading

FDA Issues First Ever Mandatory Recall Order for Kratom Products

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory … Continue Reading

FSMA Update: FDA Revises Q&A Draft Guidance on Food Facility Registration

By way of background, on July 14, 2016, FDA issued a final rule to amend and update the Agency’s food facility registration requirements and implement revisions mandated by the Food Safety Modernization Act (FSMA). To support industry compliance with the updated food facility registration requirements, on November 7, 2016, FDA issued a Draft Guidance for … Continue Reading

FSMA Update: FDA Issues Q & A Draft Guidance Regarding Food Facility Registration

The FDA has issued Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition)” As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements,see e.g., here, here, and here. On November 7, 2016, the FDA issued a Draft … Continue Reading

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