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FDA blocks heparin imports from 22 Chinese companies

Filed February 24th, 2012 Joshua Sophy

The Food and Drug Administration has issued an import alert for 22 Chinese companies which it believes are distributing adulterated products used to make the blood thinning drug heparin.

The import ban stops any shipments from these 22 companies based in China which manufacture heparin, a widely used drug most often after surgeries to prevent blood clots. In 2008, two Chinese companies were found to be selling a counterfeit version of the Active Ingredient in heparin to Baxter International, distributors of heparin worldwide.

Heparin containing this adulterated product was blamed on 81 deaths in the U.S. The discovery of the contaminated heparin prompted the recall of 13 drug products which contain it. Subsequent investigations revealed the makers of the contaminated Active Ingredient had never been inspected by the FDA because the spellings of the Chinese company were very similar to those previously inspected by the agency. Foreign drug suppliers are typically only visited by FDA inspectors once every 5 or 10 years while the agency relies on third-party inspection reports for much of its data. This lax regulation allowed another manufacturer of an adulterated heparin ingredient to get its product into the drug’s worldwide supply.

The FDA’s ban on imports from 22 Chinese companies of any heparin-related products is a follow-up to a previous action. According to a brief from InPharmaTechnologist.com, the action includes some companies already blocked from importing products to the U.S. The FDA determined these 22 companies are selling adulterated heparin products.

To remove itself from this import ban list, the company must submit third-party inspection reports to the FDA showing it is following safe manufacturing practices. These reports will then be used by the FDA to determine which facilities it will inspect before lifting the ban.

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