August 8, 2020

Volume X, Number 221

August 07, 2020

Subscribe to Latest Legal News and Analysis

August 06, 2020

Subscribe to Latest Legal News and Analysis

FDA to Resume Prioritized Food Facility and Other Domestic Inspections Based on New Risk Assessment System

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced that it will be restarting on-site prioritized domestic inspections, including food facilities, during the week of July 20 after pausing such inspections since March due to the COVID-19 pandemic. FDA will pre-announce prioritized domestic inspections to ensure the safety of the investigator and business employees as well as the availability of on-site staff to assist the investigator with inspection activities.

FDA will use its new COVID-19 Advisory Rating system (COVID-19 Advisory Level) to determine when and where to safely conduct prioritized domestic inspections. The Advisory Level is based on three metrics: 

Based on these three metrics, FDA will identify which level of regulatory activity may occur in a given geographic region: 

  • Mission critical inspections only;

  • All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population; or 

  • Resumption of all regulatory activities. 

The Advisory Level will be available to FDA’s state partners who are under contract to carry out inspections on the agency’s behalf.

Investigators will wear personal protective equipment and adhere to guidance issued by the Centers for Disease Control and Prevention, as well as state and local agencies. FDA’s resumption of on-site prioritized domestic inspections will depend on data about the trajectory of the virus in a given geographic region, rules and guidelines put in place by state and local governments, and the availability of other services such as public transportation.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 195

TRENDING LEGAL ANALYSIS


About this Author

Sarah Brew Food Attorney Faegre Drinker
Partner

Sarah Brew has a national reputation for effectively defending food industry clients against labeling and class action consumer fraud claims and representing food processors, distributors and retailers in foodborne illness and contamination cases and supply chain disputes. She also assists food and dietary supplement clients with compliance matters.

Food Litigation Defense

Sarah has served as national counsel in foodborne illness cases arising from many major outbreaks, involving products such as eggs, spinach,...

1 612 766 7470
James Sawyer, Drinker Biddle Law Firm, Chicago, Trade Law Attorney
Partner

James L. Sawyer counsels clients in all areas of U.S. import laws and regulations, including tariff classification, valuation, origin determination and marking, Free Trade Agreements, and duty preference programs. He chairs the firm’s Customs and International Trade Team and is the Regional Partner in Charge of the firm's Chicago office.

James represents clients in enforcement proceedings and investigations, Focused Assessment audits, and other verification proceedings conducted by U.S. Customs and Border Protection (CBP). He frequently assists clients craft responses to formal CBP Requests for Information and Notices of Action, which are often precursors to more aggressive CBP enforcement proceedings. 

312-569-1156
Kevin P. Boot Product Liability Attorney Faegre Drinker Biddle & Reath Des Moines, IA
Counsel

With nearly two decades of experience, Kevin Boot counsels food, feed and dietary supplement makers on national and international issues and regulations affecting their business. An experienced advisor on food labeling, advertising and marketing compliance, he understands the client’s perspective and needs after spending 15 years in-house in legal and regulatory affairs positions with leading food and feed companies. He collaborates closely with clients to decrease their litigation and enforcement risk while developing and marketing outstanding food products.

Regulatory Compliance...

515-447-4772
Associate

Karmina Fefferman advises clients in the food, dietary supplement, over-the-counter drug, and cosmetic industries on compliance with Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requirements. She assists companies preparing to launch new products by reviewing product formulations, labeling, and product classifications. Karmina also provides guidance on substantiating marketing claims in compliance with FTC and National Advertising Division standards and works closely with clients to mitigate their enforcement and litigation risk.

Past Experience

...

312-356-5041