FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

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FDA Updates Health Information Advisory on Melamine Contamination

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,000 retail markets and have not found Chinese infant formula present on shelves in these markets.

In addition, the FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.

FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk proteins. Additionally, FDA is sampling and testing milk and milk-derived ingredients and finished food products that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein. This sampling and testing is done when these ingredients or products are imported into the United States or found during visits to Asian markets. If the products are adulterated because they contain melamine and/or a melamine analog, FDA will take action to prevent the products from entering the U.S. food supply.

In addition to state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

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United States and China Outline Progress on Agreement on Food and Feed Safety

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue (SED).

“Today's progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products exported to the United States from China,” Secretary Leavitt said. “I'm very pleased with our efforts and commend our Chinese counterparts for their commitment to this important work.”

The MOA, signed during the third session under the SED in December of 2007, established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. Since its signing, HHS’ Food and Drug Administration (FDA) and AQSIQ have planned a joint implementation work strategy and have begun the initial steps called for under the agreement.

The statement describes progress in several important areas:

• Establishment of a mechanism for cooperation on significant events related to food and feed safety, including designated points of contact, emergency contacts, and thresholds for notifications; enhancing the exchange of information on the safety of food and feed safety; and developing a better understanding by both sides of each others’ respective regulatory systems.
• Development of concrete steps that will lead to a system whereby AQSIQ will electronically certify to FDA that specific products sent for export to the United States meet FDA standards for safety and manufacturing quality.
• Focus efforts on inspections and supervision and laboratory testing standards to ensure food and feed safety. The United States agreed to conduct training for Chinese officials on U.S. regulatory standards and requirements.
• Establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.

HHS/FDA and Chinese officials continue to work on implementing a second Memorandum of Agreement signed in December to enhance the safety of a variety of medical products.

For more information on the December 2007 MOA on the Safety of Food and Feed, go to http://globalhealth.gov/news/agreements/ia121107b.html.

To view the Joint Progress Statement Regarding the Five-Year Work Plan under the MOA, visit http://www.fda.gov/bbs/topics/news/international/progress_HHS_China.pdf.