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BY OUR PHARMA CORRESPONDENT
July 31, 2005: The USFDA has announced an injunction closing operations at Florida's Pharmakon Labs, which manufactures and sells cough and cold liquids, tablets and caplets.
The FDA move follows an inspection by its team, which showed that the company did not meet current good manufacturing practice (cGMP) standards and other legal requirements.
Judge Lazzara said that he was "simply unwilling as a court of equity to place the health, safety, and welfare of the general public at risk in order to accommodate the economic well-being of Defendants." Thus, company
was ordered to shut making and selling the medicine till it it complied with CGMP standards to the satisfaction of FDA.
FDA Commissioner Dr. Lester M. Crawford said: "This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards. As the nation's top enforcer of manufacturing standards, the FDA will continue to ensure that drugs being sold in this country meet those crucial requirements."
FDA said that Pharmakon has a long history of violations of American laws. The government's initial complaint alleged numerous manufacturing violations documented in four inspections dating back to 2001. FDA later added charges related to several Pharmakon drugs which are unapproved. The FDA move aganst the drug maker comes as part of the agency's policy to seek relief for all legal violations by a firm at the same time.
The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.
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