DOJ Throws the Book at Owners of Two NJ Supp Companies
Two NJ dietary supplement companies have been found guilty of criminal contempt for violating a consent decree with the FDA over violations of current good manufacturing practice (CGMP) regulations.
The defendants’ businesses manufactured and distributed food products and supplements, including many varieties of protein powder mixes, as well as other powder mixes and dietary supplements. The products were distributed under the American Sports Nutrition brand and many other private labels to locations throughout the United States.
The complaint in the civil case that led to court order alleged that the defendants, which included Mohamed S. Desoky, Quality Formulation Laboratories Inc., and American Sports Nutrition Inc., adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (CGMP) requirements, and causing the adulteration of food by preparing it under insanitary conditions whereby it may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).
…The consent decree that settled the civil action required that defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting FDA’s approval to reopen. The criminal contempt charges alleged that Ahmad Desoky and Omar Desoky, with knowledge of the court’s order, assisted their father, Mohamed S. Desoky, in violating the order, and thus were 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 upon its entry by setting up operations at a separate location in Congers, N.Y., to which they transported their employees and equipment. In addition, the petition alleged that the defendants violated the decree by failing to notify FDA of this relocation of their operations. All five defendants were found guilty of these charges.
Nice. Rather than clean up their operations, they figured they could just give the FDA the finger and set up shop somewhere else.
They’ll be sentenced in September.
