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:12/2/2016)... Raleigh, NC (PRWEB) , ... December 02, 2016 , ... ... the Open Enrollment Period (or Annual Election Period), is ending December 7th. Currently-enrolled Medicare ... plan (Part C) or prescription drug plan (Part D) need to make changes during ...
(Date:12/2/2016)... ... ... With the number of pain management programs available for people suffering with ... that works for them. When an inventor from Suisun City, Calif., was unsuccessful in ... share it with others. , He developed a prototype for PRO GO MASSAGE to ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi ... be included in the 2016 “Guide to America’s Top Plastic Surgeons” for seven ... amalgamation of their education, experience, and professional associations. , One the most ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet is proud to announce ... covers the innovative treatments, therapeutic technologies, and revolutionized nutrition that are helping patients ... life 6 years in the last 3 decades,” says Dr. Valentine Fuster, a ...
(Date:12/2/2016)... Honolulu, Hawaii (PRWEB) , ... December 02, 2016 ... ... 3, 2016 at the Hyatt Regency Waikiki Beach Resort and Spa in Honolulu, ... (CME) in the field of pain management. , The demand for supplemental ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... -- Eli Lilly and Company (NYSE: LLY ) ... updated financial guidance for 2016 on Thursday, December 15, ... that day with the investment community and media to ... conference call will begin at 10 a.m. ET. Investors, ... webcast of the conference call through a link that ...
(Date:12/2/2016)... , December 2, 2016 Orthopedic ... & Support) is Expected to Gain a Significant Market Share ... Orthopedic Ailments  ... , According to a ... on Medical Implants Sterile Packaging: Clamshell Product Type Segment Projected ...
(Date:12/2/2016)... Research and Markets has announced the addition of ... Markets and Companies" to their offering. ... , , ... The market value of drug delivery technologies and the anticancer drugs ... according to organs involved and the types of cancer as well ...
Breaking Medicine Technology: