Fake US Agent Used for FDA Registration by Chinese Companies
[Thursday, June 18, 2020] More than 1300 Chinese companies used one fictitious address and US Agent information to register with the FDA and exported products to the US that did not meet US requirements, and it may be the tip of an iceberg. Preliminary searches on FDA’s database for registered device manufacturers include 13,751 Chinese device companies, which represent more than 25% of all device manufactures registered with the FDA. With US based device manufacturers at 28,839 or a little more than 52% of the device manufacturers selling in the US, more than half of all imported devices in the US come from China. The Chinese companies in the above case used a loophole in the FDA registration process for device manufacturers whereby anyone can register online on FDA’s website with practically no verification. A US agent is an important contact for the FDA. This is an individual that is legally responsible to keep FDA updated on the compliance status of the company he/she represents, and serves as the primary contact for FDA, in case FDA has a question or needs to schedule an inspections, or handle recalls. Having a US agent is a requirement for importers into the US. However, there are no qualifications or certifications needed to act as an US agent for a non-US manufacturer; the only requirement being a physical US address and phone number. Almost all communications from the FDA are via emails or letters mailed to the address provided. FDA does not have a process to authenticate the accuracy of the information provided. And that is the loophole exploited by unscrupulous manufactures in a foreign country with no major consequences to breaking the US laws. To avoid having to pay a US person to represent as an US Agent, Chinese manufacturers used a local Chinese company which used a fake US address and contact information to register with the FDA. The only reason they were caught was because FDA decided to recall defective products from a few of these companies and could not reach the US Agent at the fake phone number, and letters were returned from the address. It is hard to imagine that this is an isolated case. And it is equally logical to assume that a company that cuts corners in such a basic and most inexpensive of the FDA requirements (a US Agent generally costs a few hundred dollars per years), does not cut corners in quality operations and compliance requirements. Foreign manufacturers represent a critical component of the supply chain in the US, unlike any other country in the world. For FDA to not have a basic process to at least authenticate the registration information seems too little to ask, and too simple to not do. Otherwise fraudulent players will keep finding ways to game the system and, in the process, hurt the US consumer. |
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