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Federal Judge Enters Consent Decree Against Utah Compounding Facility
The FDA has obtained a court order shutting down a Utah drug-compounding facility that it accused of making and distributing adulterated, unapproved, or misbranded products.
U.S. District Judge Robert J. Shelby has entered a consent decree of permanent injunction between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah; two of the company's co-owners, William O. Richardson and Rachael S. Cruz; and chief operating officer Jeffery D. Brown. The consent decree prohibits Isomeric, its owners, and its chief operating officer from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements.
According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs, that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.
The FDA most recently inspected Isomeric from February 22 to March 24, 2017. Following the FDA inspection, because of a lack of sterility assurance for its purportedly sterile drug products, Isomeric agreed to a voluntary nationwide recall of all lots of unexpired drug products produced for sterile use and distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016, and February 7, 2017.
Previously, the FDA inspected Isomeric in August 2015 and observed similar poor conditions and practices for sterile drug production. Despite assurances that Isomeric was correcting its violations, a follow-up inspection in June 2016 revealed that the company had not implemented adequate corrective actions. Following this inspection, the FDA issued a warning letter to Isomeric.
Isomeric initially registered as an outsourcing facility in July 2015 and re-registered in December 2015 and January 2017.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
Source: FDA; August 4, 2017.