Posts from — January 2012

The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) today announced the designation of Guatemalan national Marllory Dadiana Chacon Rossell and seven other individuals and entities connected to Chacon Rossell’s drug trafficking and money laundering organization as Specially Designated Narcotics Traffickers (SDNTs). Today’s action, taken pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act), prohibits U.S. persons from conducting financial or commercial transactions with these entities and individuals and freezes any assets the designees may have under U.S. jurisdiction.

 Marllory Dadiana Chacon Rossell leads a drug trafficking and money laundering organization based out of Guatemala with operations in Honduras and Panama that supplies the Mexican drug cartels.  Chacon Rossell is believed to be one of the most prolific narcotics traffickers in Central America.  She is responsible for transshipping thousands of kilograms of cocaine per month through Guatemala, into Mexico, and on to the United States.  Chacon Rossell is also believed to launder tens of millions of U.S. dollars in narcotics proceeds each month, making her the most active money launderer in Guatemala.

“Marllory Chacon’s drug trafficking activities and her ties to the Mexican drug cartels make her a critical figure in the narcotics trade,” said OFAC Director Adam J. Szubin.  “By designating Chacon, OFAC is disrupting those activities and closing off from the U.S. financial system the network of companies aiding Chacon’s illicit activities.”

OFAC is also designating Jorge Andres Fernandez Carbajal, Chacon’s husband, a Honduran citizen responsible for providing logistical support for his wife’s organization.  Hayron Eduardo Borrayo Lasmibat and Mirza Silvana Hernandez De Borrayo, both Guatemalan nationals, are also being designated today for providing support to Marllory Chacon’s drug trafficking activities.   OFAC is also designating two Guatemalan companies, Bingoton Millonario and Revoluciones Por Minuto Aceleracion S.A., which are owned, controlled, or directed by Mirza Silvana Hernandez de Borrayo and Hayron Eduardo Borrayo Lasmibat, and two Panamanian companies, Andrea Yari S.A. and Fer’Seg S.A, which are owned, controlled, or directed by Jorge Andres Fernandez Carbajal.

OFAC coordinated on this investigation with the Drug Enforcement Administration.  Today’s action is part of ongoing efforts pursuant to the Kingpin Act to apply financial measures against significant foreign narcotics traffickers and their organizations worldwide. The Treasury Department has designated more than 1,000 individuals and entities pursuant to the Kingpin Act since June 2000.

Penalties for violations of the Kingpin Act range from civil penalties of up to $1.075 million per violation to more severe criminal penalties. Criminal penalties for corporate officers may include up to 30 years in prison and fines up to $5 million. Criminal fines for corporations may reach $10 million. Other individuals face up to 10 years in prison and fines pursuant to Title 18 of the United States Code for criminal violations of the Kingpin Act.

Company Making, Marketing and Distributing Adulterated and Unapproved Drugs

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections 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 the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

In a recent release by The American Society of Health-System Pharmacists :

A shutdown of the Novartis facility that manufactures Endo oral pain medications was announced today by both Endo and the Food and Drug Administration (FDA). The action was prompted by rare reports that one or more doses of the wrong medication were found in bottles or unit-dose packages, as well as packaging problem noted by FDA during a mid-December inspection. Affected products include oxymorphone, oxycodone with acetaminophen or aspirin, morphine extended release and hydrocodone with acetaminophen.

A recall was not initiated based on the high potential for serious shortages with disruption in care and the low risk of receiving mixed-up products. Endo has warned that short-term supply disruptions may occur. FDA issued a public health advisory this morning that includes guidance for patients and the healthcare community.