Another Entry from the FDA’s Warning Letter Inbox

It has been a while since I reported on warning letters issued by the U.S. Food and Drug Administration (FDA) as part of its inspection, compliance, enforcement and criminal investigation activities. Well this post shows that the FDA continues to put violators on notice. As described in a previous article on this blog, FDA warning [...]

Entries from the Medicare Fraud File

In an earlier article on this blog, we presented examples of possible Medicare fraud schemes as identified by the U.S. Department of Health and Human Services (HHS).  The point was clear: fraudsters prey on the vulnerable and lure people in with the promise of “painless” financial reward.  These fraudsters create a façade of legitimacy and [...]

The Face of Medicare Fraud

We don’t need an expert to tell us that fraud costs money.  Health care fraud costs the system money.  The irony is that we are the “system” – all of us who receive our health care services in the U.S. are victimized by fraudsters because they steal the resources that belong to us; resources that [...]

FDA Warning Letter to a Dietary Supplement Manufacturer

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

U.S. Health Care Fraud Prevention and Enforcement Efforts

Directly or indirectly, we all have heard of fraud in the system that is designed to cater to the health of Americans.  Few of us are aware of the magnitudes of the fraud and the greed of the perpetrators.  It turns out that the schemes often involve millions of dollars of fraudulent charges to health [...]

FDA Warning Letter to a Pharmaceutical Manufacturer

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

FDA Warning Letter to a Clinical Investigator

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

FTC Permanently Stops Six Affiliate Marketers from Using Fake News Sites

As part of its ongoing crackdown on bogus health claims and false advertising, the Federal Trade Commission (FTC) conducted enforcement sweeps in 2011 against marketers who allegedly used fake news sites to promote weight-loss products.  The FTC alleged that the marketers designed websites, which falsely appear as if they were part of legitimate news organizations. [...]

FDA Warning and Close-Out Letters

As part of its regulatory compliance activity, the U.S. Food and Drug Administration (FDA) issues warning and close-out letters.  There are three types of warning letters, reflecting the nature of the compliance violation and the corrective action required from the violator. This article describes each type of warning letter, and provides a backdrop to our subsequent [...]

FDA Enforcement Report – January 18, 2012

The FDA publishes a weekly Enforcement Report, which details product recalls and field correction activity of the agency.  It is a vital resource for both industry and consumers.  Each report provides information about recalled products, including:      product name and code manufacturer and/or distributor volume of product in circulation geographical distribution of product reason [...]