FDA Forces Pharmakon Lab Shutdown

The US Food and Drug Administration (Rockville, MD) last Tuesday slapped Pharmakon Laboratories (Tampa, FL) with a permanent injunction forcing the company to shut down operations. The company manufactures and distributes cough and cold liquids, tablets, and caplets.

Following inspections by FDA and a trial in US District Court, Judge Richard A. Lazzara found that drug products sold by Pharmakon did not meet current good manufacturing practice standards and other legal requirements. This isn't the first time Pharmakon's manufacturing practices have been questioned. In September 2001, the company received a warning letter citing failure to label proper dosage; failure to establish qualification for manufacturing equipment ancillary systems; failure to validate or establish written procedures for the validation of equipment operations, water quality, or computer software used to calculate batch formulations, and failure to periodically monitor the quality of water used for manufacturing and cleaning.

Judge Lazzara stated in a release 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." The defendants were ordered to halt manufacturing and distributing drugs until they meet FDA’s CGMP standards and receive marketing approvals.

"This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards," stated FDA Commissioner Lester M. Crawford. "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."