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Investigating Quality Incidents

Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more

Counterfeiting Headaches Aren’t Just for High Fashion Retailers and Designers Anymore

When people think of counterfeit products, they envision high-end designers, such as Prada, Louis Vuitton, Gucci and Hermes, expensive accessories such as Rolex watches, and expensive fragrances. They also are likely to...more

Counterfeiting Headaches Aren’t Just for High Fashion Retailers and Designers Anymore.

There was a time, not all that long ago, where counterfeiting of consumer goods was largely a problem afflicting high fashion designers, such as Prada, Gucci and Versace. Expensive high-end accessories such as Rolex watches,...more

FDA Warns That Topical Pain-Relief Products Containing CBD Violate FD&C Act

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a ...more

CBD Health Claims Raise FTC’s Hackles (And Prompt Class Action Suits)

Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more

Ransomware Attacks Continue Unabated in the Era of COVID

On June 9, the Beazley Group, a specialty insurer affiliated with Lloyd’s Underwriters, issued a pointed reminder that, as we continue to fight the global pandemic of COVID-19, the cyber pandemic of ransomware continues....more

Blue Bell Creameries Pleads Guilty to 2015 Listeria Outbreak, Former CEO Charged

The United States Department of Justice (DOJ) announced that it had reached an agreement with Blue Bell Creameries of Brenham, Texas, to permit the company to plead guild to two misdemeanor counts of distributing adulterated...more

DOJ Charges California Physician with COVID-19 Fraud

On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in...more

FTC and FCC Take Joint Action to Stop COVID-19 Scam Robocalls

On April 3, 2020 the Federal Trade Commission (FTC) and the Federal Communication Commission (FCC) announced that they had issued Warning Letters to VoIP providers: SIPJoin, Connexum and VoIP Terminator d/b/a BLMarketing....more

FDA Takes Steps to Speed COVID-19 Imports

On April 3, the U.S. Food and Drug Administration (FDA) posted a notice that it has created a special email address in order to assist importers who are experiencing delays bringing COVID-19-related supplies into the...more

DHS-CISA Updates Guidance on Essential Industries

On March 28, 2020, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19...more

CISA Guidance Clarifies “Essential Industry” for Healthcare

On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19...more

DOJ Takes First Action against COVID-19 Fraud

On March 22, 2020, the U.S. Department of Justice (DOJ) issued a press release announcing its first action against COVID-19 fraudsters: a civil complaint seeking an injunction ordering the website coronavirusmedicalkit.com to...more

FDA Reassures on Safety of U.S. Food Supply

Amidst concerns over the rapid spread of COVID-19, on March 24, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Policy and Response Frank Yiannas issued a statement advising Americans that “there is no...more

FDA Announces Modified Inspection Protocols

In order to ensure the safety and health of its workforce and regulated industry, on March 18, the U.S. Food and Drug Administration (FDA) announced that it was suspending routine domestic facility inspections in order to...more

FTC and FDA Take Joint Action to Stop COVID-19 Fraud

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more

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