Rick Quinn, Principal at FDAImports.com, and Shelly Li, Regulatory Specialist of ExportToUsa.com.cn, traveled to China to visit companies listed on FDA Import Alert in March.

The team intended to increase Chinese companies’ awareness and understanding of FDA rules and regulations, as well as how to successfully export FDA-regulated products to the United States. During this trip, the team visited companies throughout  the provinces of Guangdong and Hainan. They visited industry members involved with food (mainly seafood), cosmetics, devices, etc.

Companies showed great interest in what FDAImports.com has to offer, especially in learning more about … READ MORE

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If you remember only one thing about FDA-related legal matters involving imported products it should be this:  Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.

For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company.  FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed … READ MORE

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