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.
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