Monday, April 8, 2019
Department of Justice Alleges Unsanitary Conditions at Dallas-Based Guardian Pharmacy
Department of Justice Alleges Unsanitary Conditions at Dallas-Based Guardian Pharmacy: The Department of Justice filed a complaint in U.S. District Court for the Northern District of Texas alleging that JMA Partners Inc., a compounding pharmacy doing business as Dallas-based Guardian Pharmacy Services, and their owner Jack R. Munn failed to rectify unsanitary conditions at their drug-compounding facility. The District Court for the Northern District of Texas entered a consent decree of permanent injunction which will stop the defendants from 'distributing adulterated, misbranded, and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.' The defendants were allegedly distributing misbranded and unapproved drugs without patient-specific prescriptions. The complaint says the drugs were prepared or stored in unsanitary conditions where they may have been contaminated. It says non-sterile disinfectants were labeled as sterile, and high humidity levels that could have lead to microorganism growth were not rectified. In 2017, the FDA issued
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