Dakota Laboratories Ceases Distribution Following Reported Violations

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Following a series of inspections that reportedly turned up potential safety issues, Dakota Laboratories will be unable to manufacture or distribute drugs until they can prove that the problems have been corrected.  This consent decree of permanent injunction was requested by the Food and Drug Administration after inspections from 2010 through 2012 turned up violations of Current Good Manufacturing Practices.  Once the company believes they have addressed the issues, another expert inspection will have to be carried out and the FDA will need to give the company the go-ahead to go back online.  At this time, there have been no reported instances of adversity associated with products from the company.

For more about the shutdown, click here.