Elizabeth Fawell

Hogan Lovells

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Food & Beverage

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FDA Finalizes Guidance on Public Warning and Notification of Recalls

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was...more

2/14/2019 / Dietary Supplements , Final Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Supply , Public Health , Public Notice , Regulatory Oversight , Regulatory Requirements

Intentional Adulteration Rule under FSMA Training Requirements and Course Availability

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the...more

12/3/2018 / Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Training , Vulnerability Assessments

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more

10/26/2018 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements

Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA...more

10/23/2018 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Recordkeeping Requirements , Regulatory Requirements

FDA Issues Update to Facility Registration Guidance and New Supplemental Draft Guidance

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility. The first document is the finalized...more

8/28/2018 / Farms , Food and Drug Administration (FDA) , Qualifying Facility , Registration Requirement , Regulatory Oversight , Regulatory Requirements , Restaurant Industry

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

6/26/2018 / Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Vulnerability Assessments

FSMA Implementation Update: FDA Releases New Supplier Verification Tool to Assist with FSMA Compliance and Provides Update on VQIP

The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more

6/4/2018 / Animal Food , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Regulatory Oversight , Regulatory Requirements , Verification Requirements

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Elizabeth Fawell

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Latest Posts › Regulatory Requirements

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