U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities. Some Chinese medical device companies allegedly used a non-existent entity with a false address as their American representative in order to register with the Food and Drug Administration (FDA) to sell personal protective equipment (PPE), including respirators and other equipment during the COVID-19 pandemic, according to the Wall Street Journal.
The investigation revealed that at least 1,300 Chinese companies listed a purportedly fictitious corporation as their U.S. agent, many of whom were given special permission to sell masks and other PPE to remedy supply shortages at the height of the pandemic. However, the purported address of that purportedly fictitious company is a residential Wilmington, Delaware home whose tenants allegedly know nothing of the company. A representative of the alleged related Chinese entity stated that the company does in fact exist.
While registration with FDA is not the equivalent of FDA approval or authorization, the investigation into the Chinese companies' registration practices highlights potential deficiencies in the process. FDA does not certify registration information. Moreover, a company who is falsifying registration information, such as the straightforward requirement to identify a U.S. agent and its address, raises critical, and perhaps life-threatening, questions about the companies' other information, including potentially the quality of its products and operations.
Among those listing the purportedly fictitious company as their agent are several Chinese companies that were given special permission during the COVID-19 pandemic to import masks meeting the Chinese KN95 standard to alleviate supply shortages of N95 masks. Yet, many of these masks were allegedly alarmingly substandard in quality, allegedly putting health care workers at risk and prompting FDA to withdraw the approvals. The lack of adequate supply of N95 masks was of serious concern from the outset of the COVID-19 pandemic. The report comes on the heels of Dr. Anthony Fauci acknowledging that the public was not encouraged to wear masks in the early stages of the pandemic because there was concern that health care workers would not have enough masks to meet the demand.
Federal prosecutors filed a criminal complaint against at least one Chinese manufacturer that listed the purportedly fictitious company as its agent, charging that the false U.S. agent listing was part of a larger attempt by the company to cover up the poor quality of its misbranded N95 respirators by distributing false documents attesting to their authenticity.
As the COVID-19 crisis continues, Seyfarth Shaw attorneys are closely monitoring FDA's reactions to the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.
Originally published by Seyfarth Shaw, on June 2020