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, [...]