|
|
Article: FDA ups enforcement on marketed unapproved drugs, as KV draws seizure.
- Article from:
- Inspection Monitor
- Article date:
- August 1, 2008
- Author:
CopyrightCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
FDA is placing stronger emphasis on compliance enforcement on manufacturers that produce unapproved drugs, which account for approximately two percent of the 3.6 billion prescriptions filled in the United States annually, officials announced July 17.
And, just 13 days later on July 30, FDA made good on its promise, by initiating a seizure of about $24 million in unapproved medications from KV Pharmaceutical Co., St. Louis.
According to an agency announcement, the confiscation followed an investigation of several KV Pharmaceutical plants, where federal agents discovered cases of non-compliance with FDA regulation and illicit manufacturing of unapproved ...