News & Analysis as of

Inspections The United States Food and Drug Administration

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

by Arnall Golden Gregory LLP on

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

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

by Kelley Drye & Warren LLP on

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

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

FDA Implements a New “Concept of Operations” for Drug Inspections

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

by Hogan Lovells on

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

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

by 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

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

by Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

Food and Beverage News and Trends - July 2016

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Beverage industry considers court action against Philadelphia’s soda tax. The...more

Major Federal Food Safety Law Depends on Individual State Enforcement

by Varnum LLP on

In 2011, Congress approved the FDA Food Safety Modernization Act in response to several deadly outbreaks of foodborne illnesses. These outbreaks convinced legislators and food industry groups that the then-existing food...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

by Thompson Coburn LLP on

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

by Arnall Golden Gregory LLP on

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

by Mintz Levin on

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

FDA Food Safety Modernization Act Imposes New Requirements on Imported Food

by 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

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

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

The Food Safety Modernization Act and What It Means to You

The Federal Food Safety Modernization Act passed in the Senate. Right now, bills are going through both the House and Senate that focus upon insuring that the food we buy to eat is indeed safe for all of us. The Senate just...more

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