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Scientific Laboratories Inc hit with injunction

The US Food and Drug Administration is cracking down on companies that break drug safety regulations and has hit Scientific Laboratories with a manufacturing injunction
The US Food and Drug Administration (FDA) is cracking down on companies that break drug safety regulations and has hit Scientific Laboratories with a manufacturing injunction.

Scientific Laboratories did not seek FDA approval for several of its key cough and cold medicines and has been barred from manufacturing any more drugs until it brings its operations in line with regulatory guidelines. A complaint was originally filed by the US Department of Justice which said the company violated the Federal Food, Drug and Cosmetic Act (FD&C Act) and did not adhere to the stipulations of current good manufacturing practice requirements (CGMP).

"The FDA will not allow a company to put the public's health at risk," said Dr Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research. She explained that the unapproved drugs could pose serious health and safety risks.

Under the terms of a signed consent decree of permanent injunction, the FDA has ordered Scientific Laboratories to destroy all stocks of unapproved drugs and retains the right to shut down the company should it commit further violations. The firm also faces fines of $5,000 for each day that it does not conform to the requirements of the decree.

Margaret Glavin, associate commissioner for regulatory affairs, said the FDA will pursue legal sanctions against companies that endanger public health by flouting laws in place to regulate drug production and marketing.

"The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs," Glavin concluded.

16th May 2008

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