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Sterile Drug Scandal Exposed: Franck’s Crimes Unfolding in Florida Courts
Florida – In a shocking turn of events, a permanent injunction has been entered against Paul W. Franck, former owner and operator of numerous compounding pharmacies, to enjoin the distribution of certain sterile drugs products, according to a recent federal court ruling.
‘The American people must be protected from compounded sterile drugs that pose a risk to the public health,’ said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. ‘The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.’
The U.S. District Court for the Middle District of Florida entered the permanent injunction at the request of the Food and Drug Administration (FDA), which alleged that Franck violated the federal Food, Drug and Cosmetic Act (FDCA) by causing drugs to become adulterated and misbranded while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
As alleged in the complaint, Franck has owned and operated numerous compounding pharmacies in the state of Florida over the past 20 years and he was responsible for providing final approval for all decisions concerning manufacturing and quality operations. The complaint alleged that the defendant and/or his employees manufactured, processed, packed, labeled, held and/or distributed drugs, including sterile drugs such as antibiotics, antivirals, cardiovascular drugs, drugs for pain management and total parental nutrition.
In conjunction with the filing of the complaint, Franck agreed to settle the case. The permanent injunction entered by the court requires that Franck cannot manufacture, hold or distribute any sterile drugs at or from his facility unless and until his facility, equipment, processes and procedures used to manufacture, hold, or distribute drugs are established, maintained, operated and administered in conformity with the permanent injunction and all applicable laws and regulations and are adequate to prevent such drugs from becoming adulterated or misbranded as defined in the order.
The FDA inspection of Franck’s Lab Inc., doing business as Trinity Care Solutions in May 2014, found conditions establishing that the drugs manufactured and distributed by the defendant were adulterated. For example, FDA observed dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the sterile manufacturing area, the area where non-sterile gowns were stored and donned, and the sink where employees prepared for sterile processing.
The FDA inspection also found other insanitary conditions, such as lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction; lack of positive air pressure in the clean room relative to surrounding rooms which compromises the cleanliness of the clean room’s air; and materials around the laminar flow hood’s vent that were not cleanable and were potential sources of viable and non-viable particles.
The complaint alleged that the defendant violated the FDCA by causing articles of drug to become adulterated, in that they are prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health, while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
Key Facts
- State: Florida
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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