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Food and Drug Administration (FDA) › Criminal Liability

Gardner Law

FDA Violations and the Park Doctrine Threat

Gardner Law on

Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know about the activities leading to the violation....more

BakerHostetler

Note of Caution to Compounding Pharmacies

BakerHostetler on

Key Takeaways: ..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012. ..Individuals face criminal liability for misrepresentations made to FDA. ...more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

Oberheiden P.C. on

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Oberheiden P.C.

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on

21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more

Saul Ewing LLP

The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know

Saul Ewing LLP on

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more

McDermott Will & Emery

Florida Federal District Court Rules GRAS Regulation Preempts Florida Statute Criminalizing Ingredient

McDermott Will & Emery on

In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation...more

Cooley LLP

Blog: Q3 Government Settlements Round-Up: Life Sciences

Cooley LLP on

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019....more

Stinson LLP

The Proposed Corporate Executive Accountability Act - Bending the Space-Time Continuum to Find Criminal Culpability of Corporate...

Stinson LLP on

Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more

Searcy Denney Scarola Barnhart & Shipley

FDA Checks Reveal Stores Illegally Sell Tobacco to Minors

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration’s crackdown on Big Tobacco continues. The agency sent warning letters to 55 point-of-purchase locations that sell cigarettes and related products in an effort to underscore newly passed...more

The Volkov Law Group

Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs

The Volkov Law Group on

In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son, Peter, under the “responsible corporate officer” doctrine (aka Park doctrine)...more

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