The U.S. Food and Drug Administration (FDA) has filed a complaint against SciLabs Nutraceuticals, Inc. and its CEO Paul Edalat, seeking to permanently enjoin them from distributing dietary supplements that are adulterated due to the alleged failure to, among other things, test product ingredients, establish product specifications, prepare batch production records, document manufacturing practices, and establish and follow written quality control procedures. United States v. SciLabs Nutraceuticals, Inc., No. 14-1759 (U.S. Dist. Ct., C.D. Cal., filed November 4, 2014). These alleged shortcomings apparently came to light during January and February 2014 inspections of the company’s Irvine, California, facility and follow previous deviations from good manufacturing practices documented in 2012 and 2013.
FDA seeks an order enjoining the defendants from distributing dietary supplements until it complies with the law and allowing FDA to inspect its places of business to ensure continuing compliance with the injunction’s terms.