WARNING LETTER
Professional World Store
MARCS-CMS 612406 —
April 27, 2021
Product:
Medical Devices
Recipient:
Professional World Store
167-43 147th Ave
Jamaica
,
NY
11434
United States
info@professionalworldstore.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
DATE: April 27, 2021
Re: “KN95 Specialised Face Mask”, “3-Layer Disposable Surgical Masks” and “3 Layer Disposable Masks For Kids”
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.professionalworldstore.com on February 26, 2021. The FDA has observed that your websites offer the “KN95 Specialised Face Mask,” “3-Layer Disposable Surgical Masks,” and “3-Layer DisposableMasks For Kids” for sale in the United States. Based on our review, these products are devices because they 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, 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 websites revealed the following representations 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:
Under a “Medical” tab, your websites, www.professionalworldstore.com, display images of and link to the products’ individual webpages
“Blocks 95.99% of bacteria, dust, chemicals, particles, pollen and smoke. Medical-grade mask: KN95…” [https://professionalworldstore.com/collections/cat-medical/products/kn95-specialised-face-mask-5-masks-per-box]
“Blocks bacteria, virus, dust, chemicals, particles, pollen and smoke…” [https://professionalworldstore.com/collections/cat-medical/products/3-layer-disposable-surgical-masks-50-masks-per-box]
“Protect your children effectively against bacteria, dust, pollen, and pollution. Medical-grade, disposable face masks…” [https://professionalworldstore.com/collections/cat-medical/products/3-layer-disposable-masks-for-kids-50-masks-per-box]
The KN95 Specialised Face Mask, 3-Layer Disposable Surgical Masks, and 3-Layer Disposable Masks for Kids are offered for sale in the United States without marketing approval, clearance, or authorization fromthe FDA. Accordingly, the products are 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). These products are 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 KN95 Specialised Face Mask and 3-Layer Disposable Surgical Masks are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. Specifically, your websites contain a number of false or misleading representations, including but not limited to:
“Our KN95 mask is FDA approved (Certificate no. BTK20200210001FDA) and has been certified to be effective and preventative in its use.” A “Certificate of Conformity” (Certificate) is positioned underneath this statement. Although much of the text found on the Certificate is illegible, the Certificate has the overall look of an official government document, incorporating unauthorized use of the FDA logo.
1
[https://professionalworldstore.com/collections/cat-medical/products/kn95-specialised-face-mask-5-masks-per-box]
Unauthorized use of the FDA logo displayed alongside images of and information about the KN95 Specialised Face Mask [https://professionalworldstore.com/collections/cat-medical/products/kn95-specialised-face-mask-5-masks-per-box]
Unauthorized use of the FDA logo displayed alongside images of and information about the 3-Layer Disposable Surgical Masks [https://professionalworldstore.com/collections/cat-medical/products/3-layer-disposable-surgical-masks-50-masks-per-box]
FDA has not approved or “certified” the KN95 Specialised Face Mask, so statements to the contrary are false. In addition, the display of the Certificate incorporating the unauthorized use of the FDA logo and the unauthorized use of the FDA logo displayed near images of and information about the products are misleading because such representations imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products. The representations on your websites 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 KN95 Specialised Face Mask and 3-Layer Disposable Surgical Masks have been approved, cleared, authorized, certified, endorsed, or otherwise evaluated by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue registration certificates to medical device establishments. 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 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 websites, product labels, and other labeling and promotional materials to ensure that you do not make representations that misbrand the product(s) 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 address 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 products are 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# 612406 or CTS Number CPT2001836when 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 Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
Delta International
167-43 147th Ave
Jamaica, NY 11434
Email: info@deltaintl.net
____________________________
1
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
).
Content current as of:
07/06/2021
Regulated Product(s)
Medical Devices