Elizabeth Fawell

Elizabeth Fawell

Hogan Lovells

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FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more

10/1/2018  /  Federal Pilot Programs , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Standards , Safety Inspections , Supply Chain

FDA Issues Update to Facility Registration Guidance and New Supplemental Draft Guidance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FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

6/26/2018  /  Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Vulnerability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

FDA Finalizes Extension of Compliance Date for Nutrition Labeling Final Rules

The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and...more

5/7/2018  /  Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Regulatory Oversight , Regulatory Standards

FSMA Implementation Update (March 2018)

There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics: - Guidance on application of the Foreign Supplier...more

3/27/2018  /  Agricultural Sector , Farm Animals , Farms , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , FSVP , Imports , Regulatory Oversight , Regulatory Standards , Wine & Alcohol

FDA Publishes List of All General FDA Form 483 Inspection Citations for Every Food Facility Since 2008

The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008...more

3/26/2018  /  Citations , Food and Drug Administration (FDA) , Food Safety , Food Supply , Public Health , Safety Inspections

FDA Publishes List of FSVP Importers Under FSMA

The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation....more

3/26/2018  /  Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , FSVP , Importers , Imports
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