FDA issues import alerts against 22 Chinese heparin suppliers
The US FDA has issued import alerts against 22 Chinese heparin suppliers it claims ship adulterated product.
Issuing the import alert allows the US Food and Drug Administration (FDA) to seize products from the companies without a physical inspection. It is unclear if any of the suppliers now sell to US-based companies.
Some of the companies were covered by earlier import alerts but for most this is the first regulatory action. Each of the suppliers is accused of having inadequate GMPs (good manufacturing practices).
Companies that want to overturn their import alert should give the FDA inspection reports from third-party facility visits. The FDA uses this information to prioritise requests for plant inspections.
