Sunday, June 14, 2020

1300 Chinese Businesses Can't be Wrong

      It was reported in the national media yesterday that the FDA has cited a number of Chinese corporations for violating Federal rules for foreign medical device makers.  A Federal prosecutor
has filed a complaint in court.   What happened now?  Well, we've read about new American companies running afoul of various rules as states scramble to access PPE for medical workers and assorted others in the community in response to the pandemic of Covid-19.
     A certain Chinese operator signed up 1000+ companies @$700 ea. and told them they would be duly registered in the US as a certified medical device manufacturer with the FDA.  All were connected to an address in the state of Delaware at a private home, owned by the Zappa family and leased to another occupant.  Each company then must pay an annual registration fee of $7000.  But wait.   How can these foreign companies follow the rules that require, among other things, a physical presence during business hours 5 days a week?  Answer: they can't, and were not even told of that little detail.  
     Result, companies decertified; broker on hook.  Now moved his latest location from Delaware to Colorado.  We'll see how it all plays out as the PPE saga in the USA unfolds.
China resident: Chengdu

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