Navigation Links
United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs
Date:3/2/2009

Company Agrees to Permanent Injunction

WASHINGTON, March 2 /PRNewswire-USNewswire/ -- The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs, the Justice Department announced today. At the same time, KV agreed to the injunction in a consent decree.

The FDA conducted inspections of KV facilities between December 2008 and February 2009 and found that the St. Louis-based company had committed significant violations of the Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMP) regulatory requirements and continued to manufacture unapproved drugs. As a result of FDA's inspections, KV recalled products manufactured and distributed from its facilities. Those recalled products will be destroyed.

Under the terms of the agreement reached with the government, the defendants cannot resume manufacturing and distributing drugs until an independent expert, retained by KV, conducts a comprehensive inspection of the company's facilities and certifies that they are in compliance with the FDCA and CGMP, and FDA gives written notification that they can resume operations. Thereafter, the consent decree requires defendants to retain an independent expert to conduct audit inspections of the company's drug manufacturing operations to ensure they remain in compliance. The inspections must occur once every six months for a period of no less than two years and annually thereafter for an additional three years.

The agreement states that should the defendants fail to comply with the consent decree, FDCA or GCMP in the future, it empowers FDA to order the defendants to cease operations, recall drug products and/or take other correction actions. The consent decree also imposes liquidated damages on KV if it fails to comply with any of its provisions.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Americans United for Life Action: Nominating Governor Sebelius to HHS is Offensive and Divisive
2. United Concordia Dental Enhances Its Web-Based Find a Dentist Tool
3. United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
4. The Forensic Specialties Accreditation Boards Comments on the National Academy of Sciences Report - Strengthening Forensic Science in the United States
5. United Spinal Association Introduces The Veterans Health Council: Improving Veterans Health through Information and Advocacy
6. Experts in Government, Public Health, Public Policy and Science Outline Blueprint for Reducing Death and Disease From Tobacco in the United States
7. United States Joins Suits Against Scios and Johnson & Johnson
8. United States Patent Office Rejects KCIs Patents
9. National Dental Insurer United Concordia Successfully Launches Real-Time Claims Processing with Tesia-PCI
10. United Kingdom House of Commons Safety Group Recommends Carbon Monoxide Screening by Pulse CO-Oximetry(TM) to Reduce Misdiagnosis and Prevent Deaths
11. Break-through Drug for Heart Failure in Dogs Now Available in the United States
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... ... March 28, 2017 , ... Z-Medica, LLC, ... of Pittsburgh Medical Center (UPMC) will acquire QuikClot® Bleeding Control Kits® (BCK) to ... developed in association with efforts by the American College of Surgeons, U.S. Department ...
(Date:3/28/2017)... ... 28, 2017 , ... The Radiology Business Management Association (RBMA) is ... its new executive director. Mr. Still was selected through a careful months-long search by ... he is known to our members, has been a part of building the RBMA ...
(Date:3/28/2017)... ... 28, 2017 , ... Qualidigm , the mission-driven national ... a new, more expansive office space in order to accommodate its growing number ... office building in Wethersfield, Conn. located at 936 Silas Deane Highway and immediately ...
(Date:3/28/2017)... ... March 28, 2017 , ... ... corrosive ions found in power plant water and steam. , Chlorides and sulfates ... and boilers, leading to extensive maintenance and unplanned shutdowns. Monitoring these ions at ...
(Date:3/28/2017)... ... March 28, 2017 , ... Columbus OH. Dr. Justin ... one of few medical professionals in the country to sit on the 2017 National ... Aesthetics, in just 2 years Dr. Harper helped propel the clinic from a small ...
Breaking Medicine News(10 mins):
(Date:3/28/2017)... Mass. , March 28, 2017 ... company developing innovative therapeutics that address significant unmet ... a patent from the Japan Patent Office (JPO) ... connective tissue growth factor (CTGF) for the treatment ... limited to skin fibrosis and proliferative retinopathy (Japanese ...
(Date:3/28/2017)... England , March 28, 2017 ... collaborative research with Cambridge ... Therapeutics Consortium   The Milner Therapeutics Institute today ... Consortium. Elysium Health has committed significant investment for collaborative projects ... the next four years. This is the first major research ...
(Date:3/27/2017)... March 27, 2017 Therapix ... pharmaceutical company specializing in the development of cannabinoid-based drugs, ... in the United States ... representing 40 ordinary shares of the Company, at ... Therapix has granted the underwriters a 45-day over-allotment ...
Breaking Medicine Technology: