CFSAN Issues Updated Guidance on Food Facility Registration

FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016). Publication of this dra… Read More
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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act. See generally Food fo… Read More
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Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents ac… Read More
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Doom and Gloom Challenges for Success Under FSMA

Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and animal food that have been sent to the Federal Register? Have you taken preliminary steps in your operation in advance of these r… Read More
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FDA Tweaks Its Guidance on Food Facility Registration

FDA has released a revised guidance document on food facility registration: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition). The revised guidance adds only one new question and answer to the 34-page g… Read More
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FDA Tweaks Its Four Foundational FSMA Proposed Rules

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA). Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Animal… Read More
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