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FSMA Update: FDA Issues Q & A Draft Guidance Regarding Food Facility Registration

The FDA has issued Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition)”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.

  • On November 7, 2016, the FDA issued a Draft Guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition):  Guidance for Industry.”  The Draft Guidance contains 15 sections of a multi-section guidance which sets forth the Agency’s current thinking on FDA’s registration requirements.  Of note, FDA has issued a revised (Seventh Edition) version of this Draft Guidance as Level 1 Draft Guidance pursuant to 21 CFR 10.115, and includes additional questions and answers relating to the Amendments to Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016) that revised FDA’s registration regulations and other questions and answers regarding food facility registration.  The new questions and answers are identified with the date that they were added to the Guidance with the newest revisions marked as “[Added November 2016].”  The issuance of this Draft Guidance comes in the midst of the 2016 Food Facility Registration biennial renewal period which began on October 1, 2016 and will end on December 31, 2016.

  • Comments on the Draft Guidance may be submitted to FDA at any time, but comments received by February 6, 2017 will be considered in the drafting of the final version of this Guidance.

© 2022 Keller and Heckman LLPNational Law Review, Volume VI, Number 314
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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