At least 1,300 registered Chinese medical device companies have listed CCTC Service Inc. in Delaware as its U.S. agent, although the company uses a false address and does not have a working phone number, reports The Wall Street Journal.
The Journal's findings highlight flaws in the FDA's medical device database and shows gaps in the FDA's coronavirus response program.
A special agent with the Food and Drug Administration in a federal court complaint filed June 5 said there is "probable cause to believe CCTC is a fictitious corporation" and suggested foreign manufacturers often do so to "circumvent regulatory oversight."
"Obviously there is a flaw in FDA's system of enforcing or regulating who is being listed as a U.S. agent," said David Lennarz, president of Registrar Corp., which helps companies navigate the FDA process and is one of the largest U.S. agents.
The occupants and owners of the residential address listed in Delaware said they had no knowledge or any connection to CCTC.
All foreign manufacturers must have a U.S. representative so the FDA can contact them about inspections, recalls, or other urgent issues.
The top 10 medical devices registered using CCTC Service Inc. include N95 masks, surgical respirators, surgical apparel accessories, non-surgical isolation gowns, N95 respirators with antimicrobial/antiviral agents, personal protective shields, and operating room shoe covers, all used heavily by medical facilities during the coronavirus pandemic.