WARNING LETTER
World Packaging Solutions, LLC
MARCS-CMS 612824 —
June 28, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Jim Sonsalla
World Packaging Solutions, LLC
3901 NW 79th Ave, Suite 245-1468
Miami
,
FL
33166
United States
js@wpkgs-ppe.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
DATE: June 28, 2021
Re: “Purvigor KN95 Mask”
Dear Jim Sonsalla:
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address https://wpkgs-ppe.com/purvigor-kn95-masks/ on May 18, 2021. The FDA has observed that your website offers the “Purvigor KN95 Mask” for sale in the United States. Based on our review, the product is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
FDA’s review of your website revealed the following statements that establish that the products are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including but not limited to:
• Representing that the Purvigor KN95 Mask is intended for use in offering an “anti-infection layer to help protect”, “anti-flu”, “anti-bacterial”, and “PFE [Particle FiltrationEfficiency] ≥ 95% BFE [Bacterial Filtration Efficiency] ≥ 95%” [https://wpkgs-ppe.com/product/purvigor-kn95-mask]
The Purvigor KN95 Mask, which your website indicates is manufactured by “Guangdong Fei Fan Mstar Technology Ltd.” (Guangdong), is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
In addition, the Purvigor KN95 Mask is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to Guangdong’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. See 21 CFR 807.39.
Your website contains a number of false and/or misleading representations, including but not limited to:
• Stating that the Purvigor KN95 Masks are “FDA Registered – NIOSH Tested – CDC Listed.” [https://wpkgs-ppe.com/purvigor-kn95-masks/]
• Stating “Approved, FDA EUA Appendix A List” alongside Purvigor KN95 Mask product information. [https://wpkgs-ppe.com/product/purvigor-kn95-mask/]
• Displaying the FDA logo
1
on the Purvigor KN95 Mask packaging. [https://wpkgs-ppe.com/product/purvigor-kn95-mask/]
• Displaying a “Certification of Registration”, issued by “Shenzhen CTB Testing Technology Co., Ltd” (Shenzhen Certificate) under the “Certification” page on your website. The Shenzhen Certificate “certifies that Guangdong Fei Fan Mstar Technology Ltd. … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The Shenzhen Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo1 and an illustration of an eagle and a U.S. flag (or a similar flag). [https://wpkgs-ppe.com/certifications/]
• Displaying a screenshot of what appears to be a previous entry for Guangdong Fei Fan Mstar Technology Ltd in FDA’s Establishment Registration & Device Listing Database. [https://wpkgs-ppe.com/certifications/]
Taken together, display of the Shenzhen Certificate, bearing the FDA logo, stating the product is “FDA Registered” and “Approved, FDA EUA Appendix A List,”
2
and displaying a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the Purvigor KN95 Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Guangdong Fei Fan Mstar Technology Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Although the Shenzhen Certificate for Guangdong contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the product has been reviewed and approved by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue device registration certificates to medical device establishments, including to sellers and manufacturers. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database merely denotes that the establishment has provided certain information to FDA.
This letter is not meant to be an all-inclusive list of violations that exist in connection with the product(s) or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you do not make representations that misbrand the product in violation of the Act.
This letter notifies you of our concerns and provides you with an opportunity to address them. Please notify this office in writing within fifteen 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of any actions your firm has taken. If your firm’s planned actions will occur over time, please include a timetable for implementation of those activities. Your firm’s response should be comprehensive and address all violations included in this letter. If you believe that the product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the Document number CMS Case Number 612824 or CTS Number CPT2000983 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov.
Sincerely,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
Shiyuan Wang
Guangdong Fei Fan Mstar Technology Ltd
A1 workshop, No.10, Dongnan Xincun Avenue, Zone 2,
Caobian No.3 Industrial Zone,Dali Town, Nanhai District
Foshan Guangdong, CN 528200
Shenzhen CTB Testing Technology
First floor, E building, Huayang
Technology Industry Park,
Gushu Village, Bao'an District,
Shenzhen City, P.R.C
_______________________
1
The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at:
https://www.fda.gov/about-fda/website-policies/fda-logo-policy
)
2
The Purvigor KN95 Face Mask offered for sale on your website appears to be the KN95 model manufactured by Guangdong Fei Fan Mstar Technology Ltd., which was removed from Appendix A of the Emergency Use Authorization (EUA) for Imported, Non-NIOSH Approved Respirators Manufactured in China (updated February 18, 2021) on May 7, 2020. As indicated in the EUA, a respirator model that has been removed from Appendix A is included in a list of respirator models whose authorization has been revoked. The list of removed respirators is maintained on FDA’s EUA webpage (
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#nolongerauth
).
Content current as of:
07/06/2021
Regulated Product(s)
Medical Devices