KV Pharma - Pharma manufacturing consent decrees
Start Date: 2009
Financial penalties: none
End Date: still pending
Product recalls involving oversized tablets and other causes, which followed FDA discovery of manufacturing problems in a 2008 inspection, ultimately led to this far-reaching consent decree. It stretches beyond KV to subsidiaries Ther-Rx and ETHEX, all three of which were forced to stop manufacturing and distribution operations due to adulteration and, for some drugs, lack of market approval. ETHEX, ultimately, was shuttered.
The regulator enlisted the help of U.S. Marshalls, who seized more than $24 million in products following KV's continued production after the FDA-ordered halt. KV hired GMP expert Lachman Consultants to oversee the production restart, a process that's still underway.