WASHINGTON – The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs, the Justice Department announced today. At the same time, KV agreed to the injunction in a consent decree.
The FDA conducted inspections of KV facilities between December 2008 and February 2009 and found that the St. Louis-based company had committed significant violations of the Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (CGMP) regulatory requirements and continued to manufacture unapproved drugs. As a result of FDA’s inspections, KV recalled products manufactured and distributed from its facilities. Those recalled products will be destroyed.
Under the terms of the agreement reached with the government, the defendants cannot resume manufacturing and distributing drugs until an independent expert, retained by KV, conducts a comprehensive inspection of the company’s facilities and certifies that they are in compliance with the FDCA and CGMP, and FDA gives written notification that they can resume operations. Thereafter, the consent decree requires defendants to retain an independent expert to conduct audit inspections of the company’s drug manufacturing operations to ensure they remain in compliance. The inspections must occur once every six months for a period of no less than two years and annually thereafter for an additional three years.
The agreement states that should the defendants fail to comply with the consent decree, FDCA or GCMP in the future, it empowers FDA to order the defendants to cease operations, recall drug products and/or take other correction actions. The consent decree also imposes liquidated damages on KV if it fails to comply with an of its provisions.