Florida Manufacturer of Skin Products Agrees toConsent Decree to Resolve Allegations of FDCA Violations
Justice Department Takes Action On Behalf of FDA
WASHINGTON – The Justice Department, at the request of the Food and Drug Administration (FDA), today filed a complaint and a consent decree in the U.S. District Court for the Middle District of Florida against Hill Dermaceuticals Inc., Hill Labs Inc., Jerry S. Roth and Rosario G. Ramirez. The complaint and consent decree are being filed today in accordance with an agreement with the defendants resolving numerous allegations of violations of the Food, Drug, and Cosmetic Act.
The defendants manufacture and distribute prescription drug products, including scalp oil, body oil, eardrops, skin cream and medicated shampoo used in the treatment of dermatitis, otitis and other skin conditions. Hill Labs manufactures drug products and sells them to Hill Dermaceuticals, which markets and distributes them. Roth is the president of both corporations, and Ramirez is quality assurance manager.
The government’s action today is the culmination of a series of inspections by the FDA of Hill’s Sanford, Fla., facility various times from 2004 to 2010. In the course of these inspections, the FDA documented numerous deficiencies in Hill’s current good manufacturing practices (CGMPs). CGMPs provide for systems that assure proper design monitoring, and control of manufacturing processes and facilities. This includes establishing strong quality management systems, obtaining appropriate raw quality materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls not only helps to prevent instances of contamination, mix-ups, deviations, failures and errors, but ensures that drug products, such as those produced by Hill, meet their quality standards. Hill’s alleged CGMP violations concerned various aspects of their manufacturing processes, their testing methods, and their quality control procedures, in addition to their facilities and equipment.
In addition, the defendants allegedly submitted falsified data in support of at least two new drug applications. The complaint alleges that Hill’s wrongful acts raise significant questions regarding reliability of any data that originated at Hill’s Sanford facility.
Under the consent decree, an expert must certify that defendants are in compliance with the law before their products are manufactured or distributed. In addition, the defendants are also required to retain an expert to review and correct the data integrity and reliability problems that the FDA documented.
“When companies report false data to the FDA and fail to meet important manufacturing standards, they undermine the accountability process Congress put in place to protect public health,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “Today’s consent decree will ensure that Hill engages the experts, processes and procedures necessary for sustained compliance and safe products.”
The resolution of this matter was handled by Trial Attorney Drake Cutini of the Justice Department’s Consumer Protection Branch and Michael Helbing, Assistant Chief Counsel, Food and Drug Administration.