FDA update – February 6, 2011

Federal Government obtains permanent injunction
against a company in Texas

Federal government made announcement on January 18, 2011 of permanent injunction against a company in Texas. The action was taken due to violation of federal law with respect to manufacturing and distributing unapproved and misbranded drug products. A company management has agreed to enter into “consent decree” with the FDA, which prohibits them from manufacturing and distributing drug products until all activities are compliant with the required standards.

It is a Texas based contract manufacturing company and was engaged mainly in producing and distributing Prescription and over-the-counter (OTC) drug products. They mainly violated the rules and regulations of Federal Food, Drug, and Cosmetic Act. The primary violations listed are as below:

• Failed to obtain required FDA approval for Prescription drug products
• Noncompliance with regulations governing OTC drug products
• Failed to comply with current Good Manufacturing Practices

This injunction is the result of significant and subsequent violations after warning letters issued by the FDA. The conditions did not improve after getting warning letter but got worse because cGMP was disregarded and company continued to manufacture and distribute new unapproved products.

As per FDA notice, company must recall all products that were distributed and manufactured since October 31, 2008. This recall should be achieved up to retailer level and all recalled products must be destroyed. If company fails to comply with the consent decree requirements, they will be penalize of $2500/day and additional $500 for each violation

For more information on this issue you can go to the following link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240272.htm  or contact mdi at info@mdiconsultants.com