A consent decree of permanent injunction signed this month by Federal Judge William D. Quarles, Jr. in the District of Maryland, bars Scientific Laboratories, Inc., its president Rajeshwari Patel, and chief executive officer, Amit Roy from manufacturing and distributing drug products. The injunction is in place until the company's operations are in compliance with the law.

The complaint filed by the U.S. Department of Justice alleged that the company sold adulterated drugs, in that the method or facility or control of the drugs were not in conformity with good manufacturing practice requirements (CGMP). During inspections in 2007, the FDA found several CGMP violations including failures to have written procedures for production and process control; failure to establish accuracy, sensitivity, specificity and reproducibility of testing methods; and failure to establish scientifically sound sampling plans. Other drugs are claimed to be misbranded.

Scientific Laboratories is also alleged to have manufactured and distributed numerous unapproved drugs. These prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. As the drugs had not undergone FDA review or approval, the safety and effectiveness of the drugs and the adequacy of the warnings have not been established.
The FDA had previously warned Scientific Laboratories against violating the FD&C Act and about enforcement that would be taken if the company failed to take corrective measures.

In addition to a stop in manufacturing, the defendants must destroy the already-manufactured illegal drugs, and also allows the FDA to order the defendants to shut down in the event of future violations. The defendants face liquidated damages in the amount of $5,000 per day if they fail to comply with any of the decree's provisions of the decree.

More information available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01837.html

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