FDA Reviewed More than 1300 Chinese Manufacturers Using FDA Agents in Violation

Release time:

2020-06-17 11:33

According to Wall Street, more than 1300 Chinese medical device companies registered to sell protective equipment and other equipment in the United States have used illegal FDA agents during the COVID-19 period. A Test Technology Co., Ltd., headquartered in Shenzhen, is one of the many FDA certification services in China and is also well-known in the industry. CCTC Services Inc. listed in numerous FDA records. It was never officially established in the United States, and gave false addresses and invalid phone numbers.

According to FDA regulations, all foreign medical device manufacturers must have an agent with a real address in the United States. These U.S. agents are the focal point between the Food and Drug Administration and these overseas companies to coordinate inspections, recalls or other urgent needs.

At least 1300 registered Chinese companies are in trouble because they have commissioned non-compliant FDA agents in China. Federal prosecutors last week filed a criminal complaint against a Chinese manufacturer that listed CCTC as its U.S. agent, alleging that the form was part of a false registration document.

The FDA filed criminal charges against King Year Printing and Packaging Co.Ltd after the company breached its registration to export N95 masks to the United States.

FDA investigators said in a complaint filed in federal court in Brooklyn, N. Y., that the agent did not respond to e-mails and "it is possible to believe that CCTC is a fictitious company." The investigators added that foreign manufacturers using fictitious U.S. agents often do so to "circumvent regulatory oversight".

Nearly 10,000 masks and respirators were registered with the FDA between March and May, most of them foreign-made. About 16 percent of these medical device companies list CCTC as their U.S. agents, according to an analysis by the Wall Street Journal.

If a U.S. agent appointed by a foreign manufacturer doesn't have the proper contact information, that's "a huge problem," said Vernessa Pollard, a former FDA enforcement lawyer who is now a partner at the McDermott law firm Will & Emery.

She said: "If there is a problem with the product for some reason, or the product needs to be recalled, the registration agent is the main way for the FDA to contact the manufacturer." Pollard also said finding a U.S. agent was a basic requirement. "If the manufacturer falsifies this threshold information, it is easy to understand why the government may have serious concerns about other aspects of the company's operations or product quality."

What is an FDA US agent?

What is a U.S. Agent/U.S. Agent?

Any foreign agency engaged in the manufacture, preparation, reproduction, compounding, or processing of equipment or products imported into the United States must identify a U.S. agent (U.S. agent) for the agency.

Information about the U.S. agent of a foreign agency is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the agency registration process. Each foreign agency may designate only one U.S. agent. A foreign agency may also, but need not, designate its U.S. agent as its official agent. The foreign agency should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

The identified U.S. agent will need to complete an automated process to confirm that they have agreed to act as a U.S. agent. The automated process forwards the email verification request to the U.S. agency. They will be asked to confirm her/his consent to act as a representative/liaison on behalf of the foreign institution. If the U.S. agent refuses to consent (or does not respond within 10 business days), the official correspondent/owner operator of the foreign agency will be notified and a new U.S. agent must be appointed to meet regulatory obligations.

Responsibilities of U.S. Agents

S. agent must reside in the United States or have a place of business in the United States. U.S. agents cannot use a post office box as an address. The US agent cannot use only the answering service. They must be available to answer the phone or have employees answer the phone during normal working hours.

The liability of the US agent is limited and includes:

1. Assist FDA to communicate with foreign agencies,

2. Answer questions about equipment imported into the United States or foreign institutions that intend to import into the United States,

3. Assist FDA in arranging inspections of foreign institutions

If FDA is unable to contact the foreign agency directly or promptly, FDA may provide information or documents to the U.S. agency, and such action should be equivalent to providing the same information or documents to the foreign agency.

Please note that agents in the United States have no liability associated with adverse event reporting under the Medical Device Reporting Regulations (21 CFR Part 803), or the filing of 510(k) premarket notifications (21 CFR Part 807, Part E).

At present, there are many FDA certification consulting agencies on the market, and the price processing cycle is also very different, but many of them are non-compliant operations, which have now attracted the attention of FDA in the United States. After CDC list, FDA EUA revocation and other events, although many domestic manufacturers are working hard to create high-quality quality quality and establish a reputation made in China. So from the product quality, from the regulatory requirements, I hope you can choose a legal compliance organization, and Xin An Run is also willing to escort your compliance road!

Those things about the emergency plan for environmental emergencies!

Key Points of Registration and Management of Pharmaceutical Excipients under the New Deal

Those things about the emergency plan for environmental emergencies!

Key Points of Registration and Management of Pharmaceutical Excipients under the New Deal

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

Cancellation of GMP certification means stricter supervision of drug production?

The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.

Dry goods! Common technical questions and answers on new raw materials for cosmetics