Made in China: A Threat Coming To A Pharmacy Near You

It seems as though every couple of months (maybe more often as of late) we get another newsflash about dangerous goods manufactured in China. Until recently, the biggest concern was lead paint used in children's toys that were made in China, but things went downhill went 4 people died & hundreds suffered allergic reactions to Heparin that, unlike the previous Baxter Heparin issues, had been given properly. The problem, it turned out, was due to an active ingredient coming from an unlicensed plant in China. As the story has unfolded, there have been critical mistakes made along the way that lead to this debacle: the plant was not licensed, the correct plant was not inspected by the US FDA, the China's SFDA or Baxter, and Baxter didn't follow standard Chemistry, Manufacturing & Control practices to ensure quality control.

To be blunt, this was a total clusterfuck. Despite a new agreement that is supposed to enhance safety of food and feed imported from China, the Chinese have made it abundantly clear that when it comes to manufacturing of drugs/ingredients, those who import Chinese goods do so at their own risk.

Ed Silverman, at Pharmalot, notes

"But the case highlights the difficulties both sides face in improving oversight given paltry levels of staffing and funding on both sides. The FDA acknowledged that Changzhou SPL was never inspected by the FDA, contrary to its own regulations, due to what it says was a mix-up with names. The Chinese FDA apparently did not inspect the factory because it was classified as a chemicals manufacturer, not a pharmaceuticals company."

In other words, we may be SOL on this one.

Tags: health care FDA manufacturing safety quality control pharmaceuticals Health medicine CMC GMP

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