ORLANDO — The federal government, on behalf of the Food and Drug Administration, is suing a longtime Florida owner-operator of compounding pharmacies, alleging distribution of adulterated drugs.
The United States of America sued Paul W. Franck on Feb. 16 in U.S. District Court for the Middle District of Florida, alleging that Franck violated the federal Food, Drug, and Cosmetic Act by causing articles of drug to become adulterated.
According to the complaint, the plaintiff alleges that as of March 2, 2013, it had identified 47 cases of eye infections. The plaintiff holds Franck responsible because the defendant allegedly manufactured and distributed adulterated and misbranded drugs used as eye solutions.
The plaintiff seeks the following: permanent restraint from manufacturing, unless and until Franck brings his operations into compliance with the Food, Drug, and Cosmetic Act, and any further relief that the court may deem just and proper. The plaintiff is represented by Roger J. Gural of U.S. Department of Justice in Washington and William B. Schultz, Elizabeth H. Dickinson, Annamarie Kempic and Michele Svonkin of U.S. Department of Health and Human Services in Silver Spring, Maryland.
U.S. District Court for the Middle District of Florida Case number 5:16-cv-00085