1,300 Chinese medical suppliers to US use bogus registration data

More than 1,300 Chinese medical-device companies that registered to sell protective gear and other equipment in the U.S. during the coronavirus pandemic listed as their American representative a purported Delaware entity that uses a false address and nonworking phone number, according to a Wall Street Journal analysis.

All foreign manufacturers of medical devices are required to have a representative with a real address in the U.S. and somebody available during business hours. Such U.S. agents serve as a point of contact between the Food and Drug Administration and these overseas companies, to coordinate inspections, recalls or other urgent needs.

At least 1,300 registered Chinese companies have listed CCTC Service Inc. as their U.S. agent. No company by that name exists in the U.S., according to databases of corporate records.

CCTC’s purported address is a three-bedroom brick house in Wilmington, Del., whose tenants and landlord say they know nothing about CCTC or any Chinese companies.

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In the FDA’s rush to respond to the pandemic, regulatory holes have appeared in the agency’s emergency-use authorization program. The Journal’s findings highlight flaws in the FDA’s medical-device database, where a listing is commonly cited by sellers of protective masks as proof of legitimacy.

The FDA in May withdrew permission for dozens of manufacturers in China to export N95-style masks to the U.S., reversing emergency approvals the agency had granted the month before.

The FDA declined to comment on CCTC. A spokeswoman said its registration database is a helpful tool for the public but doesn’t represent FDA approval, and the agency doesn’t certify registration information.

Federal prosecutors last week filed a criminal complaint against a Chinese manufacturer that listed CCTC as its U.S. agent, charging that the listing was part of false registration documents.

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The FDA investigator said in the complaint, filed in a Brooklyn, N.Y., federal court, that the agent didn’t respond to emails and there was “probable cause to believe CCTC is a fictitious corporation.”

Foreign manufacturers who use fictitious U.S. agents, the investigator added, often do so “to circumvent regulatory oversight.”

Prosecutors alleged the manufacturer, King Year Printing and Packaging Co. Ltd., exported substandard masks to the U.S. that were falsely branded as N95 respirators, potentially putting U.S. medical professionals at risk from the virus. King Year declined to comment to a Journal reporter and hasn’t responded to the legal complaint.

“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.

Nearly 10,000 masks and respirator models were registered with the FDA in March through May, most of them foreign-made. For about 16% of them, the medical-device companies listed CCTC as their U.S. agent, according to the Journal analysis. ProPublica earlier reported that CCTC was named as U.S. agent for a large number of devices registered with the FDA this year.

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The CCTC registration details originated with China-based Shenzhen CCT Testing Technology Co., the Journal found. The Shenzhen-based company said it was behind the FDA listings that named CCTC as the U.S. agent for so many Chinese firms.

“We definitely aren’t a fake company,” said Tony Mo, a senior manager at Shenzhen CCT Testing, referring to CCTC.

Shenzhen CCT Testing advertises that it tests products and helps Chinese companies obtain FDA certification. The company charges 5,000 yuan (about $700) to serve as FDA agent—using its U.S. contact information—and file U.S. paperwork for the most basic type of mask registration, on top of the FDA’s annual registration cost of roughly $5,000, he said.

The company used a U.S. company-registration agent to assist them in establishing a U.S. presence, Mr. Mo said. The Shenzhen-based company got the Delaware address from the U.S. agent when it started working in the U.S. about two years ago, didn’t know anybody at the home and believed the address could be changed later, he said.

As for why Shenzhen CCT Testing didn’t respond to emails from U.S. investigators about King Year, Mr. Mo said the company initially thought the emails were a hoax and only later realized they were serious.

Mr. Mo acknowledged that CCTC Services Inc., the firm listed in so many FDA records, was never officially established in the U.S. This year, he said, the Chinese parent decided to establish an official presence in the U.S., and in May registered CCTC Services United Inc., based in Colorado.

A company by that name was incorporated in Colorado on May 13, state records show. About 50 companies now have used CCTC Services United Inc. as their U.S. agent, according to FDA records.

A few issues remain: 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.

Mr. Mo said Shenzhen CCT Testing is now asking clients to find their own representatives in the U.S.

“We had no idea that there was such a big responsibility involved in doing this,” he said. “We can’t take responsibility for others’ bad actions.”

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