FDA faults heparin supplier's quality control

The FDA has admonished a heparin supplier for failing to follow up on a potential contamination problem. One of the heparin makers involved in the big contamination scandal of 2008--Scientific Protein Laboratories--received a customer complaint several months later that a batch of its raw product was tainted, but didn't investigate the problem for almost a year afterward, the agency says.

As reported by the Wall Street Journal, SPL got the complaint in October 2008, but held off investigating until September 2009. At that point, it found that the contaminated raw material was used in two processed batches of heparin. The company investigated one of those batches, but didn't look into the second, the FDA says.

SPL tells the WSJ that the batches passed all the required testing for contamination, but its customer's specialized testing found oversulfated chondroitin sulfate--the same contaminant implicated in the 80 deaths and hundreds of adverse reactions from bad heparin in 2008. It said no adverse events were reported with this latest batch.

During that scandal, the companies involved defended themselves by saying they responded quickly to reports of problems and cooperated fully with the FDA. Lawmakers criticized the agency's response to the crisis. These new revelations could inspire another round of blame; Rep. Joe Barton tells the WSJ that the House Energy and Commerce Committee's staff will investigate the new report. "This is deadly serious business," Barton says.

- read the WSJ piece

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