By Stephen Daniells Nutra Ingredients USA
The owner of two New Jersey-based dietary supplement companies guilty of criminal contempt of court relating to GMP violations has been sentenced to prison for 40 months.
Mohamed Desoky owner of NJ-based Quality Formulation Laboratories Inc. and American Sports Nutrition Inc. also received a fine of $60,000, while the companies' managers Ahmad Desoky and Omar Desoky, were sentenced to 34 months of prison.
US District Court Chief Judge Garrett Brown Jr. also ordered Quality Formulation Laboratories Inc. and American Sports Nutrition Inc. to pay criminal fines totaling $1 million, and placed them on probation for a period of three years.
As reported by NutraIngredients-USA this summer, the companies and the Desoky’s were found guilty of multiple counts of criminal contempt of court for violating a consent decree.
The complaint in the civil case that led to the court order alleged that the defendants adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (cGMP) requirements.
“After the FDA found egregious sanitation and manufacturing problems at the defendants’ facility, we obtained a court order requiring the defendants to clean up their act,” said Tony West, Assistant Attorney General of the Civil Division of the Department of Justice.
“Instead of complying with that order, the defendants thumbed their nose at it and continued distributing product. The court’s appropriately stiff sentences in this case make clear the lesson: If you jeopardize the health and safety of the American people, we will hold you accountable.”
During an FDA inspection of the facility in December 2008 and January 2009, FDA investigators reportedly observed a dead rodent - cut in half- on a blender motor platform; another dead rodent was observed surrounded by rodent feces in product storage area; and a live rodent was observed running through the blending room on two occasions.
The results of the FDA inspections led to a civil action that required the defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting the thumbs up from FDA. The defendants consented to this.
However, the criminal contempt charges alleged that all three Desoky’s knowingly violated the order, and were therefore criminally liable for the violations even though they were not named as defendants in the original civil case.
The petition for criminal contempt charged all five defendants with violating the decree almost immediately – the defendant transported employees and equipment to a separate location in Congers, NY, and restarted operations. The defendants allegedly failed to notify FDA of this relocation of their operations.
The defendants were also found guilty of continuing to receive, manufacture and distribute product at their Paterson facility
At the time, dietary supplement trade associations applauded the FDA’s “strong action”.