Data shows that from March 1 to May 5, China has provided more than 6.6 billion masks to the United States. Perhaps due to China’s vigorous transfusion of medical supplies, the mask shortage in the United States has been greatly alleviated. The United States, which had just breathed its last breath, began to stage the real-life version of “The Farmer and the Snake” again and again.
The U.S. Food and Drug Administration (FDA) said on May 7, local time, that it would revoke the licenses of about 60 Chinese manufacturers to sell N95 masks in the United States. , on the grounds that the masks produced by these manufacturers do not provide adequate protection against the new coronavirus.
According to Bloomberg, the FDA revoked the licenses of about 60 Chinese manufacturers to export masks to the United States, leaving 14 companies authorized. The FDA said it is also stepping up inspections of masks imported from China and will conduct random testing of these masks.
Reuters stated that the FDA last month authorized the use of masks made in China and tested by accredited independent laboratories, even though these masks have not been tested by relevant U.S. authorities.
FDA (data map)
FDA withdraws the permission of more than 60 Chinese manufacturers to export N95 masks to the United States!
On May 7, the latest tests released by the U.S. CDC’s National Institute for Occupational Safety and Health (NIOSH) found that among 67 different types of imported N95 masks, about 60 % did not make it. On the same day, the U.S. FDA said it had withdrawn the licenses of more than 60 Chinese manufacturers to export N95 masks to the United States, reducing the number of Chinese manufacturers allowed to produce N95 masks for the United States from approximately 80 to 14.
It is understood that this overturns a decision made by the United States on April 3 to allow masks produced by manufacturers that have not been tested by U.S. authorities to be imported into the United States. As long as they meet standards set by some other country, or are reviewed by an independent laboratory.
However, according to sources, some domestic companies’ masks have not been exported to the United States, but they still found that the CDC issued a substandard report on their masks, and The attached test sample photos are not the products of its company. The CDC may also have inaccurate reporting, and the company is asking the CDC for clarification.
At the same time, on May 7, US time, the FDA issued an emergency update on the EUA for masks released on April 3. The main updated points are as follows:
1. Revise the eligibility criteria to allow authorization based on acceptable performance against standards documented by independent laboratory testing.
2. Disqualify the importer as an applicant for EUA and instruct the manufacturer to provide a list of authorized importers.
3. If it can be verified by FDA, the registration certificate of China National Medical Products Association (NMPA) is recognized.
Attachment: List of non-NIOSH-approved Chinese mask manufacturers authorized by FDA to import (updated on May 7)
Only 14 companies have obtained FDA certification
tip: Mask manufacturers exporting to the United States should pay attention
The official website of the U.S. CDC has a page with NPPTL (The National Personal Protective Technology Laboratory) mask test results. Some companies are also on the US EUA list. https://cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
After a simple comparison, the companies on the EUA list below have the following test results:
In fact, Chinese masks exported to the United States have encountered more troubles than that!
BYD sold masks to the United States and was forced to refund US$247 million!
Last month, California announced that it had reached a contract with BYD worth approximately US$1 billion and paid nearly US$500 million in advance. Under the contract, BYD will deliver 500 million masks to the state over the next two and a half months, including about 300 million N95 masks, priced at $3.30 each.
However, on May 6, local time in the United States, the California Office of Emergency Management stated that due to the failure to respond on April 30 If the certification is obtained by the deadline, BYD will refund half of the state’s advance payment, or $247 million, for a mask contract worth about $1 billion.
It is reported that this is the largest “refund” incident encountered by Chinese companies since the outbreak of the new coronavirus epidemic. The reasons for refunds all come from…”The issue of U.S. federal certification.” California Governor Gavin Newsom said that of the approximately $1 billion worth of masks ordered by the state from the Chinese company BYD, tens of millions of surgical masks have arrived, but millions N95 masks scheduled to arrive this week have been delayed due to problems in the federal certification process. He did not say what caused the certification delay.
It is worth mentioning that at present, At a time when masks are in short supply around the world, the price of the masks BYD sold to California was even half as much as the price purchased by other states in the United States. However, the mask business, which was originally a loss-making business, still encountered “routine operations” in the United States. If there is another delay, BYD may only get a payment of US$505 million in the end.
Cui Tiankai, China’s ambassador to the United States, recently mentioned a strange phenomenon in Western public opinion. He said that when China initially When providing medical supplies to the United States and European countries, some people say that China is seeking geopolitical interests. While China has introduced some measures to ensure the quality of exported medical supplies and comply with international standards, some people have begun to accuse China of obstructing the export of supplies.
Looking at the U.S. FDA’s “face-changing” operation and BYD’s painful lesson, it also serves as a wake-up call for many Chinese companies exporting U.S. masks and other medical supplies.
If current masks, protective clothing, and ventilators are exported to the United States, the relevant companies must obtain a U.S. license. Don’t think that the urgent need for anti-epidemic materials during the spread of the epidemic can overcome the license issue. Without a license, Even if they take it away now, when the epidemic is over, we will be free to get it right; even if we get the license, we still have to see clearly whether our products are good enough and whether all the indicators meet the requirements of the United States, otherwise they will pass. It’s better to tell the truth about the epidemic. We don’t have much money from the sales, which is not enough for legal fees.
Now that we have learned from the past, I think we are now the best The solution is not to export anything to the United States, so as not to incur lawsuits and lose money. Just think silently in your heart, America, come on.
The United States is the snake among farmers and snakes, Mr. Dongguo And the wolf among wolves, forget it, America is America, it’s the different fireworks.</p
