FDA faults heparin supplier's handling of tainted batch

A supplier involved in the heparin contamination scandal of 2008 has been cited by the US Food and Drug Administration for failing to follow-up a customer complaint about a tainted batch of the product.

Scientific Protein Laboratories reportedly received the complaint in October 2008, but did not initiate an investigation until September 2009, according to a Wall Street Journal article.

The WSJ also says that when it started to look into the issue, SPL failed to investigate a second batch of heparin associated with the complaint.

The contamination incident involving heparin material sourced from China led to 81 deaths in the USA and has sparked a major review of supply chain security, particularly in the area of economically-motivated adulteration.

In this case, SPL sourced material from China which was cut with oversulphated chondroitin sulphate (OSCS), a less costly substance that can mimic heparin in identity testing but provides no anticoagulant activity. It is thought the stimulus for the adulteration was a scarcity in heparin, which is sourced from pig intestines. At the time of the contamination there was a swine shortage in Asia.

SPL imported the tainted heparin ingredient from its Chinese subsidiary and sold batches to a number of drugmakers, including Baxter International. Both Baxter and SPL are facing class action lawsuits relating to their role in the scandal.

SPL told the WSJ that the heparin lots in question had passed all the required testing at the time and that it had responded quickly when the customer complaint was raised.

US Congressmen Joe Barton and Michael Burgess criticised the FDA for its handling of the crisis in an open letter to the agency published earlier this year. The latest development may lead to a reopening of that probe as Rep Barton said he would be looking into the new findings.


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