BETHESDA, MD 02 March 2009—FDA has filed an injunction against troubled drug manufacturer KV Pharmaceutical that will prevent the company and its subsidiaries from producing drugs until the firms come into compliance with the federal drug agency`s current Good Manufacturing Practice. The consent decree for permanent injunction was filed in federal court in St. Louis, Missouri, on Monday, according to a spokesman with the U.S. Department of Justice. The action prevents KV Pharmaceutical and its subsidiaries from producing any products until an independent reviewer and FDA officials approve manufacturing changes.
KV Pharmaceutical, along with subsidiaries Ethex Corporation and Ther-Rx Corporation, had experienced recent problems producing oversized pills and unapproved products. The companies recently issued a wide-ranging recall of many generic prescription products.
FDA inspections between December 2008 and February 2009 found that the company had significant current Good Manufacturing Practice violations and continued to produce unapproved drugs.
If the companies fail to comply with any part of the decree or FDA regulations, the drug agency may order the firm to again stop producing and distributing drugs, recall the products, or take other corrective actions.
"We look forward to cooperating with the FDA during this process that will facilitate our return to the market," said David A. Van Vliet, KV Pharmaceutical`s interim chief executive officer in a press release. "Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed."
According to the Department of Justice, the consent decree consent requires the companies to retain an independent expert to perform audit inspections of the manufacturing operations. The inspections must occur every six months for at least two years and then annually for the following three years.
