Other safety alerts
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| The United States: Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities |
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The US Food and Drug Administration (FDA) announces that US District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development. The company has four registered outsourcing facilities located in Memphis, Tenn.; Cleveland, Miss.; Sugar Land, Texas and Dayton, N.J. According to the complaint, despite previous warnings from the FDA and repeated promises from PharMedium to correct deficiencies, PharMedium continued to violate the law.
The consent decree prohibits PharMedium and the other defendants from, among other things, manufacturing, holding, or distributing PharMedium’s drugs at or from its Tennessee facility until it completes corrective actions and receives authorization from the FDA. The company has ceased operations at its Mississippi facility, and its Texas and New Jersey facilities must, among other things, hire an independent expert to review PharMedium’s operations at these facilities to ensure compliance with the law.
In the complaint, the government alleges that PharMedium manufactured and distributed drugs intended to be sterile such as oxytocin and morphine sulfate, 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 may have been rendered injurious to health. The complaint also alleges that PharMedium distributed unapproved new drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decree-against-compounder-pharmedium-services-violations-multiple
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company.
Ends/Thursday, May 23, 2019
Issued at HKT 15:00
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