jueves, 7 de febrero de 2019

Press Announcements > Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

Press Announcements > Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions





Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions



Pennsylvania compounder prohibited from manufacturing and distributing sterile human and animal drug products


The U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction today between the United States and Ranier’s Rx Laboratory Inc., doing business as Ranier’s Compounding Laboratory, of Jeanette, Pennsylvania, and pharmacist Francis H. Ranier, who owns the compounding facility. 

“We continue to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made, which can raise significant risks to patients. This is an area of intense focus for the FDA. We’re committed to making sure that compounded drugs are made under appropriate production standards and, when necessary, taking enforcement actions against compounders who fail to ...




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