More than 1,300 Chinese medical device companies that have reportedly registered to sell supplies in the United States have falsified their registration information.
Foreign medical supply companies are required to have an address in the U.S. with a representative that works during business hours, which allows the Food and Drug Administration to coordinate with foreign entities in case inspections, recalls, or other important actions are required.
At least 1,300 companies have listed as their U.S. agent a company called CCTC Service, the Wall Street Journal found in an analysis released Thursday. There is no record of a company by that name in the U.S. The company’s supposed address is a random home in Wilmington, Delaware. The home’s residents say they know nothing about this company. The entity’s listed phone number does not work.
A Chinese company, Shenzen CCT, says it is behind the CCTC Service listings, but that it “definitely [isn’t] a fake company.”
A senior manager for the company, Tony Mo, admits that CCTC Services was never officially established in the U.S. However, Mo claims Shenzen CCT established a new presence in Colorado in May: CCTC Services United. According to FDA records, around 50 companies have now used CCTC Services United as their U.S. agent.
But the Wall Street Journal lists a few key problems with the new agency: “Some listings for CCTC Services United with the FDA were made in March, before it was incorporated; the Colorado Springs address is at a mailbox rental store, which FDA rules don’t allow; the phone number for the new agent listed in FDA records doesn’t work.”
While the FDA declined to comment on the listings, a spokeswoman for the FDA told the Wall Street Journal that the organization’s registration database does not represent FDA approval.
