GMP Tips - Drug Company Shut Down by FDA - May 19, 2008

FDA announced last week that Scientific Laboratories Inc. signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

Read FDA's Press Release. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Tip
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