The FDA has announced a Consent Decree permanently enjoining KV Pharmaceuticals, its subsidiaries ETHEX and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The decree will remain in place until KV Pharmaceuticals and its subsidiaries sustain continuous compliance with the FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years.
Under the terms of the Consent Decree, KV Pharmaceuticals and its subsidiaries cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspection of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires that the defendants destroy all drugs they recalled between May 2008 and February 3, 2009.
For more information visit www.fda.gov/bbs/topics/NEWS/2009/NEW01965.html.