sábado, 29 de junio de 2013

Press Announcements > Federal judge enters consent decree with Med Prep Consulting

Press Announcements > Federal judge enters consent decree with Med Prep Consulting

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Sterile injectable drug compounder distributed contaminated drugs across state lines
 
A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the U.S. Food and Drug Administration.
 
Med Prep manufactured sterile drug products for hospitals and health care facilities, including products intended to be injected into the vascular system of patients.  In addition to other requirements, the consent decree enjoins Med Prep from manufacturing, holding, and distributing drug products until it complies with certain requirements of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

For more information please visit: Med Prep

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