FDA Action Prohibits Hill Companies from Introducing Adulterated Drugs Into Commerce

October 6, 2011 8:56 am

FDA has announced that Hill Dermaceuticals, Inc, and Hill Labs, Inc (collectively referred to as “Hill”) have been prohibited from introducing adulterated drugs into interstate commerce due to numerous deviations from current good manufacturing practice (cGMP) for drugs. The District Court for the Middle District of Florida entered a consent decree that prohibits Hill, and individuals Jerry S. Roth and Rosario G. Ramirez, from introducing adulterated drugs into interstate commerce. In addition to the documented deviations from cGMP, the government further alleges that Hill has, on more than one occasion, submitted untrue statements in support of submissions to the FDA. These falsified submissions are evidence of persistent data integrity problems at Hill, states FDA in a news release. Hill manufactures the following topical prescription drug products: DermaSmoothe/FS^® Scalp Oil; Dermasmoothe/FS Body Oil; and DermOtic^® Oil Eardrops. In addition, Hill is the contract manufacturer of the topical prescription drug products Tri-Luma^® Cream and Capex^® Shampoo for Galderma Laboratories. FDA notes that the agency is not currently aware of any recent adverse events related to the use of any of Hill's products, and reminds consumer and health care providers that any such adverse events may be reported using the MedWatch online form.