Tag Archives: FSMA; FDA

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FSMA Update: FDA Revises Q&A Draft Guidance on Food Facility Registration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support industry compliance with the updated food facility registration requirements, on November 7, 2016, FDA issued a Draft Guidance for … Continue Reading

FSMA Update: FDA Issues Q & A Draft Guidance Regarding Food Facility Registration

The FDA has issued Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition)” As previously covered on this blog, over the past several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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