The FDA is still investigating Scientific Protein Laboratories over a case of contaminated heparin that occurred after the headline-grabbing Baxter recall of the blood thinner in 2008. The initially recalled product was linked to more than 80 deaths.
The second SPL contamination incident, which the FDA believes posed no significant public-health risk, involved processed heparin batches made from API sourced from the drugmaker's Chinese subsidiary, according to the Wall Street Journal.
In its ongoing investigation, the FDA found that the drugmaker received a complaint from a corporate customer in October 2008 but didn't begin its own probe of the cause until September 2009. The FDA says also that SPL failed to investigate lots that may have been associated with the contaminated one, which never reached patients.
The regulator cited SPL for GMP violations, and its investigation continues. The drugmaker says that when it tested the heparin, it passed all the then-required tests. Trace amounts of the contaminant, oversulfated chrondroitin sulfate, were detected by an SPL customer.
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