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重磅!1300家中国口罩企业面临起诉,原因是FDA注册该方面的违规操作!

作者:巨东物流  |  发布时间:2020-06-16 12:01  |  来源:巨东资讯    关注量:

文章摘要: 继此前对中国口罩企业的过滤效果发难后 对中国口罩企业此前FDA注册的某些不合规 成了美方新的清算方向 第一批口罩出口赚得盆满钵满的中国企业已经开始计划逐步退出这个风口了,但是,目

继此前对中国口罩企业的过滤效果发难后

对中国口罩企业此前FDA注册的某些不合规

成了美方新的清算方向




第一批口罩出口赚得盆满钵满的中国企业已经开始计划逐步退出这个风口了,但是,目前看来他们可能很难抽身了。上周就有了报道:《美国开始对中国口罩企业秋后算账,首家企业面临1062万巨额罚款!

很多人开始以为质量问题可能是美国人秋后算账的杀手锏,但是,大家只猜对了一半,刚刚,美国开始抛出第二个清算利器:中国口罩企业提供虚假的FDA注册信息!


重磅!1300家中国口罩企业面临起诉,原因是FDA注册该方面的违规操作!


华尔街日报(WSJ)一份分析显示,超过1,300家中国医疗器材公司,在2019年冠状病毒疾病(COVID-19)肆虐期间,据称将德拉瓦州(Delaware)一个实体列为其在美国的代表,但该实体使用的,却是假地址和无人接听的电话号码


华尔街日报报导,所有外国医疗器材制造商都被要求在美国必须有一个代理机构或称代表处,此代表处必须拥有真实地址,且在营业时间有人值班接听电话。


这些公司的美国代表,是食品暨药物管理局(FDA)与这些海外公司之间的联络人,以便协调检查、召回或应付其他紧急需求。



华尔街日报的最新报道披露,仅仅从其调查的一家公司名为CCTC Service Inc的情况显示:至少1,300家注册的中国公司,将CCTC Service Inc.列为他们的美国代表。但根据公司纪录资料库,这家以CCTC Service Inc为名的公司在美国并不存在。


CCTC声称所在地址,是位于德拉瓦州威明顿(Wilmington)的一栋3房砖造房屋,该地址的房客和房东说,他们对CCTC或任何中国公司一无所知。


华尔街日报指出,CCTC的详细注册讯息源自一家名为Shenzhen CCT Testing Technology Co.的检测企业。


这家总部位于深圳的公司指出,它就是将CCTC列为那么多中国公司在美国代理人的幕后推手。


来自这家检测公司的资深经理Tony Mo在提到CCTC的时候说:“我们当然不是假的公司”。


但他也承认,这家被列在FDA众多纪录中的CCTC,从未正式在美国成立。


重磅!1300家中国口罩企业面临起诉,原因是FDA注册该方面的违规操作!


在FDA匆忙应对疫情大流行过程中,FDA的紧急使用授权计划出现监管漏洞。华尔街日报的调查结果,凸显FDA医疗器材资料库的瑕疵,防护口罩的销售商通常会援引FDA医疗器材资料库证明自身的合法性。


FDA拒绝就CCTC置评。一名发言人表示,FDA的注册资料库对大众来说是一项有用工具,但列入该资料库不代表获得FDA批准,该机构也未认证资料库中的注册资讯。


虽然FDA没有置评,但华尔街日报发布事件报道后,一些美国网友带歧视性的留言令人愤怒:


重磅!1300家中国口罩企业面临起诉,原因是FDA注册该方面的违规操作!





从目前情况来看,随着疫情逐步走稳,对中国口罩企业的清算将会是接下来一段时间的主旋律,口罩过滤效果是否达标,FDA注册信息和流程是否合规,甚至售价是否合理,这些都将是很多中国口罩企业要过的关,一旦过关失败,诉讼以及后续的高额罚款或罚金将不可避免。


以下是中国第一家口罩企业收到的美国起诉书,关于起诉的原因和即将面临的追责,值得出口美国市场的口罩企业可以仔细研究。


中国口罩企业-King Year Packaging and Printing Co. Ltd.(金年包装印刷有限公司)收到的美方起诉书原文:


UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF NEW YORK

---------------------------------------------------X

UNITED STATES OF AMERICA

 - against -

KING YEAR PRINTING AND

PACKAGING CO., LTD.,



 Defendant.

--------------------------------------------------X

COMPLAINT AND AFFIDAVIT IN

SUPPORT OF APPLICATION FOR

SUMMONS .

(T. 21 U.S.C. §§ 331(a), 333(a)(2), and 18

U.S.C. §§ 1001(a), 2)

No. 20-MJ-416

EASTERN DISTRICT OF NEW YORK, SS:

DONALD PEARLMAN, being duly sworn, deposes and says that he is a

Special Agent with the U.S. Food and Drug Administration, Office of Criminal Investigations

(“FDA-OCI”), duly appointed according to law and acting as such.

Counts One Through Three: Introduction of Misbranded Devices into Interstate Commerce

1. On or about the dates set forth below, in the Eastern District of New York

and elsewhere, the defendant KING YEAR PRINTING AND PACKAGING CO., LTD.

(hereinafter also referred to as “KING YEAR”), with intent to defraud and mislead, did introduce

and deliver for introduction, and cause to be introduced and delivered for introduction into

interstate commerce devices that were misbranded within the meaning of Title 21, United States

Code, Section 352(a)(1), specifically self-breathing filtration particle-preventive respirators

whose labeling falsely included the NIOSH logo despite the respirators not being NIOSH

approved, and “N95” markings and a test report showing compliance with the N95 standard

despite the respirators not meeting the minimum standard for N95 respirators, in the approximate

quantities set forth below. 

- 2 -

Count Approximate

Date

Approximate Quantity of

Respirators

1 4/6/20 95,200

2 4/18/20 300,000

3 4/21/20 100,000

(Title 21, United States Code, Sections 331(a) and 333(a)(2), and Title 18, United States

Code, Sections 2 and 3551 et seq.)

Count Four: False Statements

2. On or about April 10, 2020, in the District of Maryland and elsewhere, the

defendant, KING YEAR PRINTING AND PACKAGING CO., LTD., by and through the acts of

its agents and employees who were acting within the scope of their agency and employment and

with intent to benefit KING YEAR, in a matter within the jurisdiction of the executive branch of

the United States, namely, the U.S. Food and Drug Administration, did knowingly and willfully

(a) falsify, conceal, and cover up by trick, scheme, and device, certain material facts; (b) make

materially false, fictitious, and fraudulent statements and representations; and (c) make and use

false writings and documents knowing them to contain materially false, fictitious, and fraudulent

statements and entries.

(Title 18, United States Code, Sections 1001(a), 2, and 3551 et seq.)

3. The source of your deponent’s information and the grounds for his

belief are as follows:

4. I am a Special Agent with FDA-OCI. I am aware of the facts contained

herein based upon my own investigation and based upon interviews and briefings with other law

enforcement officers who have participated in this investigation. I also have participated in 

- 3 -

witness interviews and reviewed other evidence, including email and text message

communications, telephone toll records, and publicly-available reports. Because this affidavit is

being submitted for the limited purpose of establishing probable cause, I have not included each

and every fact known to me concerning this investigation. I have set forth only the facts which I

believe are necessary to establish probable cause. Unless specifically indicated, all conversations

and statements described in this affidavit are related in substance and in part.

Relevant Entities and Individuals

5. Defendant KING YEAR PRINTING AND PACKAGING CO., LTD. was

a company located in Guangdong province in the People’s Republic of China (“PRC”) that was

engaged in the business of manufacturing, exporting, and distributing products, including

personal protective equipment (“PPE”), to the United States and throughout the world.

6. Individual-1 was a U.S. citizen residing in the PRC who brokered deals for

pharmaceutical and medical products from companies located in the PRC. As COVID-19 spread

in the PRC and throughout the world, Individual-1 entered the business of buying, selling, and

importing PPE into the United States. Individual-1 held himself out to buyers in the United

States as having connections to Chinese pharmaceutical companies, medical equipment

manufacturers, provincial governmental leaders, and central government ministry leaders,

including the Ministry of Health.

7. Individual-2 was a relative of Individual-1. Individual-2 was a U.S. citizen

who resided in Salt Lake City, Utah. Individual-2 was a licensed acupuncturist and the owner

and operator of Company-1.

8. Company-1 was a Utah corporation located in West Valley City, Utah. Its

primary business involved the import and export of supplements and raw materials from the PRC. 

- 4 -

9. Individual-3 was a U.S. citizen who resided in Lincoln University,

Pennsylvania. Individual-3 owned and operated Company-2.

10. Company-2 was a Delaware limited liability company located in Lincoln

University, Pennsylvania, with warehouse space in Newark, Delaware. Prior to the COVID-19

pandemic, Company-2 imported and distributed hazmat protective suits from a manufacturer in

Italy. As COVID-19 spread in the United States, Individual-3 used Company-2 to accumulate

large quantities of PPE, including facemasks and respirators, and resell them to private brokers

and various governmental entities, medical providers, and first responders, often at substantial

mark-ups over the prices he paid to acquire the PPE.

11. Company-3 was a Chinese medicine manufacturer, importer, and

distributor located in Guangdong province in the PRC.

12. Company-4 was a Chinese import and export broker located in Jiangsu

province in the PRC.

Overview

13. Between on or about April 6, 2020 and on or about April 21, 2020, in the

midst of the COVID-19 pandemic, defendant KING YEAR PRINTING AND PACKAGING CO.

LTD. exported approximately 495,200 defective and misbranded “N95” respirators (the “Subject

Respirators”) from the PRC to the United States. The defendant KING YEAR falsely labeled the

Subject Respirators with the intent to defraud U.S. consumers, including medical providers and

state and local governments, into believing they were buying N95 respirators approved, cleared,

or otherwise authorized by the U.S. Food and Drug Administration (“FDA”) and National

Institute for Occupational Safety and Health (“NIOSH”) of the Centers for Disease Control and

Prevention (“CDC”). In fact, the Subject Respirators were neither FDA-approved, cleared, nor 

- 5 -

authorized nor NIOSH-approved. And the Subject Respirators did not perform at the promised

minimum 95% filtration efficiency level. Nevertheless, the defendant KING YEAR attempted to

cover up the poor quality of the Subject Respirators in various ways – by stamping FDA and

NIOSH logos on its packaging, by embroidering each Subject Respirator with the label, “N95,”

by procuring and disseminating false documents attesting to the authenticity of the Subject

Respirators, by filing a false registration document claiming the masks were NIOSH-approved,

and by using a fictitious corporation as its U.S. agent in registration documents filed with the

FDA.

The Global COVID-19 Pandemic

14. In December 2019, a novel coronavirus, SARS-CoV-2, was first detected

in Wuhan Province of the PRC, causing outbreaks of the coronavirus disease 2019 (“COVID19”) that have since spread globally. On January 31, 2020, the Secretary of Health and Human

Services declared a national public health emergency under 42 U.S.C. § 247d as a result of the

spread of COVID-19 to and within the United States. On March 11, 2020, the Director-General

of the World Health Organization characterized COVID-19 as a pandemic. On March 13, 2020,

the President of the United States issued Proclamation 9994 declaring a national emergency as a

result of the rapid spread of COVID-19 within the United States.

15. According to the CDC, the virus that causes COVID-19 spreads through

respiratory droplets produced when an infected person coughs or sneezes. Droplets can land in

the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those

within close proximity.

16. Accordingly, the CDC has issued guidance to health care providers

recommending that they wear PPE, such as N95 respirators, to prevent the coronavirus from 

- 6 -

being transmitted by infected patients to healthcare providers. The CDC also has encouraged the

public to use face coverings to prevent the spread of the virus. To that end, on or about April 15,

2020, New York Governor Andrew M. Cuomo issued an executive order requiring all people in

New York to wear face coverings in public.

The Surge in Demand for N95 Respirators

17. According to CDC guidance, face masks are used by the general public and

by healthcare professionals as source control, which refers to the use of a facemask or cloth face

covering over the mouth and nose to contain that individual’s respiratory secretions to help

prevent transmission from infected individuals who may or may not have symptoms of COVID19. Face masks sometimes contain ear loops, which are not designed to form a seal around the

nose and mouth.

18. A surgical mask is a loose-fitting, disposable device that creates a physical

barrier between the mouth and nose of the wearer and potential contaminants in the immediate

environment. Surgical masks are not designed to form a seal around the nose and mouth. A

picture of a surgical mask is attached below:

19. An N95 respirator is a disposable half-mask filtering facepiece respirator

that covers the user’s airway (nose and mouth) and offers protection from particulate materials at

an N95 filtration efficiency level per 42 CFR 84.170. N95 respirators are worn by both the

patient and the healthcare personnel to protect from the transfer of microorganisms, body fluids, 

- 7 -

and particulate material. An N95 respirator has headbands and is designed to achieve a very close

facial fit and very efficient filtration of airborne particles. If properly fitted, the filtration

capabilities of N95 respirators far exceed those of face masks and surgical masks. A picture of an

N95 respirator is attached below:

20. A NIOSH-approved N95 respirator is an N95 respirator approved by

NIOSH that meets the filtration efficiency level per 42 CFR 84.170. The NIOSH stamp of

approval is sought after by manufacturers and healthcare personnel alike as an indication of

safety, reliability, and performance.

21. NIOSH-approved respirators are required to have certain markings,

including the business name of the approval holder/manufacturer; NIOSH in block letters or the

NIOSH logo; the NIOSH testing and certification approval number, e.g., TC-84A-XXXX;

NIOSH filter series and filter efficiency level, e.g., N95; and the approval holder’s respirator

model number or part number, represented by a series of numbers or alphanumeric markings, e.g.,

8577 or 8577A. Below is a picture published by the CDC of a generic facepiece respirator with

appropriate NIOSH markings: 

- 8 -

22. The CDC does not recommend that the general public wear N95 respirators

to protect themselves from respiratory diseases, including COVID-19, as those are critical

supplies that must be reserved for health care workers and other medical first responders.

23. Due to the unprecedented demand for emergency medical services to treat

patients presenting with COVID-19 symptoms, hospitals and medical professionals have

experienced critical shortages of N95 respirators and other one-time usage face masks.

The Statutory Framework

24. The FDA is responsible for protecting the health of the American public by

ensuring, among other things, that medical devices are safe and effective for their intended uses

and bear labeling that contains true and accurate information. The FDA, among other things,

regulates the manufacture, labeling, and distribution of medical devices shipped or received in 

- 9 -

interstate commerce and enforces the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.

(the “FDCA”), and other pertinent laws and regulations.

25. The FDCA prohibits, among other things, the introduction, delivery for

introduction, or causing the introduction or delivery for introduction into interstate commerce of a

misbranded device. 21 U.S.C. § 331(a).

26. Under the FDCA, a medical device is misbranded if, among other things,

the labeling on the device “is false or misleading in any particular.” 21 U.S.C. § 352(a)(1).

27. Under the FDCA, a “label” is defined as “a display of written, printed, or

graphic matter upon the immediate container of any article.” 21 U.S.C. § 321(k). “Labeling” is

defined as “all labels and other written, printed, or graphic matter upon any article or any of its

containers or wrappers, or accompanying such article.” 21 U.S.C. § 321(m).

28. Under the FDCA, “interstate commerce” is defined in part as “commerce

between any State or Territory and any place outside thereof.” 21 U.S.C. § 321(b).

29. Under the FDCA, a “device” is defined, in pertinent part, as “an

instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar

or related article, including any component, part, or accessory, which is . . . (2) intended for use in

the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of

disease, in man . . . , and which does not achieve its primary intended purposes through chemical

action within or on the body of man or other animals and which is not dependent upon being

metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h).

30. Face masks, face shields, and respirators are “devices” subject to FDA

regulation when they are intended for a medical purpose, such as prevention of infectious disease 

- 10 -

transmission (including uses related to COVID-19). Face masks, face shields, and respirators are

not devices when they are intended for a non-medical purpose, such as for use in construction.

31. Under the FDCA, every person who owns or operates any establishment

within any foreign country engaged in the manufacture of a device that is imported or offered for

import into the United States shall, upon first engaging in such activity, immediately submit a

registration to FDA that includes, among other things, the name and place of business of the

establishment, the name of the United States agent for the establishment, and the name of each

importer of such device in the United States that is known to the establishment. 21 U.S.C. §

360(i)(1)(ii).

Individual-3 Agreed to Purchase N95 Respirators in the PRC from Individual-1

32. In or around March 2020, Individual-1, the American broker living in the

PRC, began sourcing PPE, including N95 respirators and COVID-19 test kits, for Individual-3,

the individual living in Pennsylvania and the owner of Company-2, from sources in the PRC.

Individual-3 intended to import and sell the products procured by Individual-1 to his customers in

the United States, including medical providers and first responders.

33. Individual-1 and Individual-3 agreed that they would use Individual-2’s

company, Company-1, to wire money to sources in the PRC and to help import the products into

the United States. Prior to the pandemic, neither Individual-2, the Utah-based acupuncturist, nor

Company-1 had experience in the PPE business.

34. From on or about March 18, 2020 to on or about March 27, 2020,

Individual-3 wired approximately $3.07 million to Company-1 for the purpose of purchasing 1

million N95 respirators. Individual-1 caused Company-1 to enter into separate agreements with 

- 11 -

two Chinese companies in the PRC, Company-3 and Company-4, to purchase a total of

approximately 800,000 NIOSH-certified N95 masks for Individual-3 in the United States.

Individual-1 Procured the Subject Respirators from KING YEAR

for Individual-3 in the United States

35. On or about March 28, 2020, via text message, Individual-1 reported to

Individual-3 that he had obtained approximately 10,000 masks for Individual-3 and expected to

obtain an additional 20,000 to 50,000 masks the following day, which he intended to start

shipping to Individual-3 in the United States. Individual-1 sent Individual-3 pictures of the

packaging for each box of masks which listed the manufacturer as the defendant KING YEAR

PRINTING AND PACKAGING CO., LTD.

36. Individual-1 provided Individual-3 with a certificate of registration

document from East Notice Certification (“ENC”) service, dated March 20, 2020, and signed by a

purported Chief Engineer at ENC. Even though ENC was purportedly a Chinese inspection

company, the document had an FDA logo, an American eagle, and purported to state that the

defendant KING YEAR PRINTING AND PACKAGING CO., LTD. was “registered with the

U.S. Food and Drug Administration pursuant to voluntary cosmetic registration program.” A

picture of the certification document prepared for KING YEAR is attached below: 

- 12 -

37. In fact, according to FDA records, the defendant KING YEAR PRINTING

AND PACKAGING CO., LTD. did not attempt to register with the FDA as a manufacturer of

N95 respirators until on or about April 10, 2020, not the March 20, 2020 date this certificate

bears. Therefore, this certificate prepared for KING YEAR by ENC and disseminated to

Individual-1 and others as a marketing tool for U.S. buyers, such as Individual-3, provided a false

impression that KING YEAR had registered with the FDA as a foreign manufacturer of N95

masks, when it had not.

38. Individual-1 also sent Individual-3, by text message, a test report prepared

for the defendant KING YEAR PRINTING AND PACKAGING CO., LTD. by ENC that

purportedly certified that the masks manufactured by KING YEAR met the NIOSH standard for

particulate filtration efficiency. The test report was from a non-accredited laboratory and appears

to have been false. The report did not include a model number or brand name for the masks

tested, rendering it impossible to verify whether the masks allegedly tested were the Subject 

- 13 -

Respirators sold to Individual-3. Additionally, the pictures of the masks depicted in the report

were generic and appeared to be different from the Subject Respirators later imported by

Individual-3 into the United States. For example, unlike the Subject Respirators, the masks

depicted in the ENC report were not stamped with any marks or logos, were not embroidered with

“N95,” and had ear loops that visibly appeared to be made of different material.

KING YEAR Put False and Misleading Claims on the Labeling of the Subject Respirators

39. On or about April 6, 2020, the U.S. Customs and Border Protection

(“CBP”) intercepted and detained a shipment of approximately 95,200 Subject Respirators at the

John F. Kennedy Airport (“JFK”) that were inbound from the PRC and destined for Individual3’s warehouse in Newark, Delaware (“Shipment 1”). Shipment 1 consisted of approximately

4,760 identical boxes of masks, with each box containing approximately twenty masks.

40. Law enforcement reviewed pictures of the Subject Respirators and the

labeling on the packaging for the Subject Respirators. The labeling on one face of each box

stated “N95,” contained the logos of FDA and NIOSH, and claimed to meet the NIOSH filtration

standard. Another face of the box contained a warning label, listed the manufacturer as the

defendant KING YEAR PRINTING AND PACKAGING CO., LTD., and again prominently

displayed the NIOSH and FDA logos. The packaging also included the logos suggesting it

complied with European Union health laws and regulations (CE) and Chinese laws and

regulations (GB).

41. Each respirator had ear loops. One side of each respirator was embroidered

with “N95.” The other side was embroidered with “CE FFP2, EN149:2001+A1:2009,” which

refers to European Union filtration standards for respirators. Below are pictures of the labeling

on the Subject Respirators: 

- 14 - 

- 15 -

42. The labeling on the Subject Respirators manufactured by KING YEAR

was false and misleading because, among other things: (i) the packaging for the Subject

Respirators displayed the NIOSH logo prominently in two places, falsely implying the Subject 

- 16 -

Respirators were NIOSH-approved (they were not); (ii) the labeling on the Subject Respirators

included the FDA logo, implying the Subject Respirators were FDA-approved, cleared, or

authorized (they were not); and (iii) the Subject Mask were embroidered with “N95” in their

fabric (they did not meet the N95 standard).

43. In addition, certifications prepared for the defendant KING YEAR

PRINTING AND PACKAGING CO., LTD. and disseminated to brokers, such as Individual-1,

falsely implied that KING YEAR was registered with the FDA as a manufacturer of N95 masks

(it was not registered until April 10, 2020, and the registration documents filed were misleading),

and that the Subject Respirators met the NIOSH filtration standard for N95s pursuant to a

purported lab test report prepared by ENC (ENC is not an accredited laboratory, and the CDC

later concluded that a sample of the Subject Respirators failed to meet the N95 filtration

standard).

Individual-3 Sold the Subject Respirators to First Responders and Medical Providers

44. Individual-3 marketed, priced, and sold the Subject Respirators as FDAapproved, NIOSH-approved, N95 respirators. In marketing materials sent to potential customers,

including healthcare providers, Individual-3 appended pictures of the false and misleading

packaging for the Subject Respirators containing the NIOSH and FDA logos, the false and

misleading ENC certification, and the false and misleading ENC test report.

45. Individual-3 then attempted to sell the Subject Respirators at prices

ranging from $4.85 to $5.85 per mask, to various entities, including, hospitals, pilots associations,

medical centers, and governments.

46. On or about April 6, 2020, a customs broker hired by Individual-3 to clear

Shipment 1 through U.S. customs raised questions concerning the intended use of the Subject 

- 17 -

Respirators and whether they should include FDA and CBP authorization codes for importation.

Individual-3 relayed these questions over text message to Individual-1 in the PRC.

47. On or about April 8, 2020, Individual-1 advised Individual-3 in a text

message to disclaim the Subject Respirators as being for medical use because the masks were

“civilian use N95 masks.” Individual 3 then instructed the customs broker to disclaim the Subject

Respirators as intended for a medical use, notwithstanding the fact that Individual-3 intended to

sell the Subject Respirators to first responders and medical providers. As a result of this false

information, FDA did not perform an initial inspection of the Subject Respirators upon arrival at

JFK.

KING YEAR Filed False Registration Documents with the FDA

48. On or about April 10, 2020, the defendant KING YEAR PRINTING AND

PACKAGING CO., LTD. filed documents with the FDA to register as a foreign exporter and

manufacturer of “[f]ace Masks, KN95, N95, N95 respirator[s] with antimicrobial/antiviral

agent[s].” This was the first time KING YEAR filed a registration document with the FDA

concerning the Subject Respirators, notwithstanding that KING YEAR manufactured and offered

the Subject Masks for import into the United States as early as in or around March 2020.

49. The defendant KING YEAR PRINTING AND PACKAGING CO., LTD.

coded its products in the registration documents as Class II medical devices and “single use,

disposable, NIOSH-approved N95 respirator[s].” KING YEAR’s registration submission further

designated its respirators as “intended for use by the general public in public health medical

emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to

pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which

kills specified pathogens under specified contact conditions.” This was false. First, KING YEAR 

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did not obtain NIOSH approval for the Subject Respirators. Instead, KING YEAR obtained a test

report from ENC, a non-accredited Chinese laboratory, falsely claiming that the Subject

Respirators satisfied the N95 standard. Second, the Subject Respirators were not intended to be

used by the general public. KING YEAR knew or consciously avoided knowing that any

respirators sold in the United States were going to be used first and foremost by healthcare

personnel on the frontlines of the COVID-19 health emergency given the widely reported

shortages of respirators in the national stockpile and in the U.S. market generally, and the CDC’s

guidance that all respirators should be reserved for healthcare personnel. By embroidering “N95”

on each individual mask and falsely marking the packages with the NIOSH logo on the

packaging, KING YEAR was actively causing the respirators to be most marketable to healthcare

personnel in the United States.

50. In the false registration documents filed by the defendant KING YEAR

PRINTING AND PACKAGING CO., LTD. with the FDA, it nominated CCTC Service, Inc.

(“CCTC”) as its U.S. agent, and listed an address for CCTC in Wilmington, Delaware, a phone

number, and an email address.

51. The responsibilities of the United States agent, include: assisting the FDA

in communications with the foreign establishment; responding to questions concerning the

foreign establishment’s devices that are imported or offered for import into the United States; and

assisting the FDA in scheduling inspections of the foreign establishment. 21 CFR 807.40(b)(2).

If the FDA is unable to contact the foreign establishment directly or expeditiously, the FDA may

provide information or documents to the U.S. agent, and such an action shall be considered to be

equivalent to providing the same information or documents to the foreign establishment. Id. In

addition, the United States agent cannot be a mailbox, answering machine or service, or any other 

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place where an individual acting as the foreign establishment’s agent is not physically present. 21

CFR 807.3.

52. The investigation revealed that the address listed by the defendant KING

YEAR PRINTING AND PACKAGING CO., LTD. for CCTC in its certification documents was

a personal residence with no affiliation to CCTC. Law enforcement interviewed the occupant of

the residence, who stated that he was a clinical psychologist who has rented the premises for three

years. The occupant had never heard of CCTC or KING YEAR. Law enforcement subsequently

interviewed the owners of the residence, both of whom stated that they had not heard of CCTC or

KING YEAR, and had never registered any company with the FDA.

53. On or about May 28, 2020, law enforcement attempted to reach out

multiple times to the phone number listed by the defendant KING YEAR PRINTING AND

PACKAGING CO., LTD. in its registration documents. Each time, law enforcement received a

message stating that the number was temporarily unavailable. Subsequent attempts to reach

anyone at that number were unsuccessful. CCTC has not responded to emails sent by law

enforcement to the email address listed for the company by KING YEAR on its registration

documents. Searches of open source records and law enforcement databases revealed no active

corporation by the name of CCTC in Delaware or elsewhere. There is, therefore, probable cause

to believe CCTC is a fictitious corporation.

54. In my training and experience, foreign manufacturers of counterfeit goods

use fictitious corporations as U.S. agents to circumvent regulatory oversight of their products.

The Subject Respirators Did Not Meet the Minimum N95 Standard

in Tests Performed by the CDC

55. On or about April 17, 2020, FDA employees reviewed photographs of the

first shipment of the Subject Respirators and found that they appeared to be misbranded. 

- 20 -

56. On or about April 18, 2020, CBP intercepted a second shipment of the

Subject Respirators at JFK intended for delivery to Individual-3’s warehouse in Newark,

Delaware. This shipment consisted of 300,000 Subject Respirators (“Shipment 2”).

57. On or about April 22, 2020, the FDA performed an initial inspection of the

Subject Respirators at JFK from Shipments 1 and 2 and confirmed that they were misbranded.

On that same day, the FDA sent a sample of 10 masks from each shipment to the CDC for testing.

58. On or about April 22, 2020, a third shipment of the Subject Respirators

arrived at JFK inbound from the PRC and was intercepted by CBP (“Shipment 3”). Shipment 3

was also destined for Individual-3’s warehouse in Newark, Delaware. Law enforcement

confirmed that the packaging for the masks in Shipment 3 appeared to be identical to the Subject

Respirators in Shipments 1 and 2.

59. On or about April 24, 2020, the CDC published the results of the tests

performed on the Subject Respirators in Shipments 1 and 2. The CDC found that all of the tested

samples measured a filter efficiency of less than the minimum 95 percent required for an N95

respirator. The filter efficiency for the masks ranged from 83.4% to 91.12% for the first sample

and 82.7% to 90.03% for the second sample. With the exception of two masks, all of the masks

tested with a filter efficiency rate of below 90%. The CDC found that despite the packaging

having the NIOSH logo and claiming that the product met the NIOSH certification standard, the

Subject Respirators were not NIOSH-approved and did not meet the NIOSH certification

standard.

60. In addition, the CDC report noted fit difficulties with the ear loop design of

the Subject Respirators, stating that “[c]urrently, there are no NIOSH-approved products with ear

loops” and that “limited assessment of ear loop designs, indicate difficulty achieving a proper fit.” 

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The fit of a respirator is critical because it is only when an N95 respirator is properly fitted that its

filtration capabilities exceed those of face masks and surgical masks, and thereby, provide greater

protection from airborne particles and respiratory droplets containing the virus.

61. The FDA Center for Devices and Radiological Health (“CDRH”)

Inspections and Audits team also reviewed the Subject Respirators from Shipments 1 and 2. In

addition to CDC’s findings, CDRH concluded that the ENC test report prepared for KING YEAR

PRINTING AND PACKAGING CO., LTD. was not from an accredited laboratory.

62. WHEREFORE, your affiant respectfully requests that a summons be issued

for the defendant KING YEAR PRINTING AND PACKAGING CO., LTD. so that it may be

dealt with according to law.

Dated: Brooklyn, New York

 June 5, 2020

Donald Pearlman

Special Agent

FDA Office of Criminal Investigations

Sworn to before me by telephone this

5th day of June, 2020

____________________________________

THE HONORABLE STEVEN M. GOLD

UNITED STATES MAGISTRATE JUDGE

EASTERN DISTRICT OF NEW YORK 


重磅!1300家中国口罩企业面临起诉,原因是FDA注册该方面的违规操作!


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文章关键词链接: FDA注册口罩企业起诉违规

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