News & Analysis as of

Inspections Food and Drug Administration (FDA) Food Safety

Holland & Knight LLP

FDA Ramps Up Actions on PFAS

Holland & Knight LLP on

With the completion of the voluntary phaseout of one form of short-chain per- and polyfluoroalkyl substances (PFAS) as a grease-proofing agent, the U.S. Food and Drug Administration (FDA) has rejected the view that...more

Hogan Lovells

Two recent developments regarding FDA inspection-related activities

Hogan Lovells on

The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more

Patrick Malone & Associates P.C. | DC Injury...

Baby formula mess shows big profits, a filthy plant, and bungled oversight

The giant drug maker Abbott and the federal Food and Drug Administration both should hang their heads in shame as more information becomes public as to how they left millions of vulnerable infants hungry and put kids’ health...more

Hogan Lovells

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

Hogan Lovells on

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

Faegre Drinker Biddle & Reath LLP

FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and...

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the...more

Hogan Lovells

COVID-19 Update: FDA Provides Update on Inspection Plans

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

Hogan Lovells on

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | March 2018 #2

US, EU Near Agreement on Shellfish Trade - The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the...more

Kelley Drye & Warren LLP

“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future...more

Akin Gump Strauss Hauer & Feld LLP

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Dickinson Wright

Are You Exempt? FDA Announces Waivers for Certain Businesses Subject to the Sanitary Transportation Rule

Dickinson Wright on

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final and on April 5, 2017, the FDA published three waivers for certain qualifying businesses. The Sanitary...more

King & Spalding

FDA Food Safety Modernization Act Imposes New Requirements on Imported Food

King & Spalding on

On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (S. 510) (FSMA), which amends the Federal Food, Drug, and Cosmetic Act (the FDC Act). The FSMA shifts the focus of the Food and Drug...more

Patrick Malone & Associates P.C. | DC Injury...

New Food Safety Law Facing Funding Hurdles

Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the...more

Sheppard Mullin Richter & Hampton LLP

President Obama Signs New Expansive Food Safety Law

In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more

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