FDA Warning Letter Jan-Apr 2021 Recap Summary

FDA Warning Letter Jan-Apr 2021 Recap Summary

May 6, 2021 | Standards

Warning Description	Products & Summary
FDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance of FDA for marketing, Violating the Regulations and so comes under adulterated and misbranded products. Manufacturer is asked to give justification in writing within 15 days and how they correct there violation and prevent reoccurrence, and timetable of implementation of the activities If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. FDA also informed “If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.”	The maker of Fever Scan temperature Scanners was selling the devices without FDA clearance or approval.
	The manufacturer of the SNAP XT PRO HID and InfinityX PRO telethermographic devices was selling the products without FDA clearance or approval.
	The manufacturer of the KOGNIZ TC 20 telethermographic device was selling the product without FDA Clearance or approval.
	The maker of the TI-120GTS thermal scanner was selling the device.
FDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance of FDA for marketing, Violating the Regulations and so comes under adulterated and misbranded products.CDRH advise manufacturer to “review websites, product labels, and other labeling and promotional materials to ensure that they are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act.Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.Failure to adequately prevent address any violations may result in legal action, including, without limitation, seizure and injunction. . If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of admission if they are offered for importation into the U.S. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.”	The maker of Artemis thermal scanners was selling the devices without FDA clearance or approval. The agency advised CreativeStar to stop selling the products, which the company falsely said could prevent COVID-19.
	The manufacturer of Du ThermaXtelethermographic devices was selling the product without FDA Clearance or approval. The agency advised Dubak Electrical to stop selling the devices, which the firm falsely said could prevent COVID-19.
	The maker of Covid-19 Sample Collection Kits was selling the devices without FDA Clearance or approval. The agency advised EnMed to stop selling the Kits.
	The manufacturer of the Sentry MK4 telethermographic devices was selling the product without FDA clearance or approval. The agency advised Ominesence to stop selling the devices, which company falsely said could mitigate and prevent COVID-19.
	The maker of Thermo-Apo MD and Thermo-App MD Pro telethermographic devices was selling the products without FDA clearance or approval. The agency advised OpgalOptronic to stop selling the devices, which the firm falsely said could mitigate and prevent COVID-19.
	The manufacturer of the LUNGENE Covid-19 at-home serology test was selling the product without FDA clearance or approval. The agency advised the company to stop selling the test.
	The maker of various screening Cameras was selling the devices without FDA clearance or approval. The agency advised Shenzhen Sunell to stop selling the telethermographic devices which the firm falsely said could mitigate and prevent COVID-19
	The maker of the Multi-person Thermal Screening Camera was selling the Telethermographic device without FDA clearance or approval. The agency advised Thermavis to stop selling the Camera, which the company said could scan multiple people at the same time. “Risks are more likely to be present where telethermographic devices scan multiple individuals simultaneously,” the agency wrote.
	The manufacturer of the FevIR Scan 2 telethermographic device was selling the product without FDA clearance or approval. The agency advised Thermoteknix to stop selling the device, which the firm falsely said could mitigate and prevent COVID-19.
	The maker of the WG 50 and WG620 telethermographicdevices was selling the product without FDA clearance or approval. The agency advised Westminster International to stop selling the devices, which the Company falsely said could mitigate and prevent COVID-19.
	The manufacture of the MEDICAS telethermographic device was selling the product without FDA clearance or approval. The agency advised workswell to stop selling the device, which the company falsely said could mitigate and Prevent COVID1-19
The U.S-FDA inspected Manufacturer’s drug manufacturing facility. During the inspection, FDA investigators determined the firm is a manufacturer of over-the-counter drug products as well as wound dressing medical devices.This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and Quality System (QS) regulations for medical devices. FDA also said:“See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211) and 21 CFR part 820, respectively. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, your firm manufactures the over-the-counter (OTC) drug product “HYPERCARE.” “HYPERCARE is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).We reviewed your October 14, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following:Drug CGMP ViolationsUnapproved New Drug ViolationsMedical Device Quality System Violations	Quality systems violations noted at the manufacturer of Sonafine Wound Dressing and Venelex Ointment Wound Dressing. Process validation activities weren’t conducted, and procedures weren’t established and maintained to control nonconforming product. Design verification procedures also weren’t established and maintained; for example, stability protocol didn’t support a two-year shelf-life for the Sonafine dressing, and the firm further failed to perform antimicrobial effectiveness testing on the dressing. Procedures for design change weren’t established and maintained; for example, the company modified raw material used in the Sonafine and Venelex dressings without validating the change. Further, the firm failed to ensure that manufacturing equipment met specified requirements. Calibration procedures weren’t established and maintained, and corrective and preventive action (CAPA) procedures didn’t include a requirement for the company to analyze quality data. (The warning letter to the firm, which also makes over-the-counter drug products, also included violations of the FDA’s drug regulations.) Tarmac Products’ response to the FDA-483 was deemed mostly inadequate by the agency.
Product Misbranded, under section 502(o) of the Act, 21 U.S.C. § 352(o), because 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). False claims like “FDA Emergency Use Authorized” statement and FDA logo on their products.Unauthorized use of the FDA logo violate federal law Products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).	SethiLaboratorie’s products “Rapid COVID-19 Antibody Self Test Kit”, “Rapid COVID-19 Antigen Self Test Kit” , are offered for sale in the United States directly to consumers to self-test at home or outside of a healthcare setting without marketing approval, clearance, or authorization from FDA.The agency advised company to justify for violations done like for the device, which the company falsely claims FDA approved and use FDA logo.Firm is ordered to take immediate action to address the violations. FDA advised the firm to review its websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that they do not make claims that adulterate or misbrand the products in violation of the Act and FDA said-Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Product Misbranded, under section 502(o) of the Act, 21 U.S.C. § 352(o), because 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). False claims like “FDA Emergency Use Authorized” statement and FDA logo on their products.Products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).	Block ScientificProducts “QUIKPACII COVID-19 ANTIBODY TEST KIT”, “Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)”, are offered for sale in the United States directly to consumers without marketing approval, clearance, or authorization from FDA.The agency advised company to justify for violations done.Firm is ordered to take immediate action to address the violations. FDA advised the firm to review its websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that they do not make claims that adulterate or misbrand the products in violation of the Act and FDA said-Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Product Misbranded, under section 502(o) of the Act, 21 U.S.C. § 352(o), because 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). False statement claims of being FDA approved.Product is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because statements on your website represent that the “COVID-19 IgM/IgG Rapid Test” is “FDA-approved.”Products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).	Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs products “COVID-19 IgM/IgG Rapid Test” , are offered for sale in the United States directly to consumers without marketing approval, clearance, or authorization from FDA.The agency advised company to justify for violations done.Firm is ordered to take immediate action to address the violations. FDA advised the firm to review its websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that they do not make claims that adulterate or misbrand the products in violation of the Act and FDA said-Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.Note: FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing.
The Akcutest Kit 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 notdenote FDA approval of the establishment or the device. Thus, references to an establishment registration that create an impression of official FDA approval of the establishment or its products are misleading and constitute misbranding. See 21 CFR 807.39. The websites reference FDA registration (e.g., “FDA registered”), at times incorporating unauthorized use of the FDA logo, alongside information about and photos of the Akcutest Kit. As displayed, such representations imply that FDA has approved, cleared, authorized, or otherwise evaluated the product. As stated above, FDA has not approved, cleared, or authorized the product. Moreover, the “disclaimer” presented, for example, in small font and placed at the very bottom of your websites stating that “[t]his test has not been reviewed by the FDA” could be easily overlooked and does not mitigate the overall impression that FDA has approved, cleared, authorized, or otherwise evaluated the product. We also note that based on our review of FDA’s Establishment Registration & Device Listing Database, an establishment with or including the name “Ikcon” is not registered and no device by the name of “Akcutest” was listed by any establishment. Therefore, statements indicating “FDA registered” also appear to be false. The Akcutest Kit and the Lumigenik Kitadulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).	Ikcon Investments, IncdbaIkcon Medical Products “Akcutest COVID-19 Antibody Test”, “Akcutest Sample Kit and “Akcutest Serological Rapid Test”) and the “Lumigenik COVID-19 Antigen Rapid Test” “Lumigenik Kit (25 tests per Kit $30/test)are offered for sale in the United States directly to consumers to self-test at home or outside of a healthcare setting with an establishment with or including the name “Ikcon” is not registered and no device by the name of “Akcutest” was listed by any establishment. Therefore, statements indicating “FDA registered” also appear to be false. False claims of being registered and not present in FDA’s Establishment Registration & Device Listing Database, selling products without marketing approval, clearance, or authorization from FDA.The agency ordered Firm to take immediate action to address the violations. FDA advised the firm to review its websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that they do not make claims that adulterate or misbrand the products in violation of the Act and FDA said-Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Fast Masks USA LLC products , under section 502(o) of the Act, 21 U.S.C. § 352(o), because 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). Company website represents that these products are “FDA Approved” or “FDA Authorized giving false impression..Products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).	Fast Masks USA LLC products “At-Home COVID-19 Test Kit,” a “COVID Test Kit (25 Tests),” and a “COVID-19 Antibodies Test Kit,” and distributes the “SKY Medical Supplies &Equipments, LLC Diagnostic Kit (Colloidal Gold) “Xiamen Wiz Biotech CO., LTD SARS-CoV-2 Antigen Rapid Test Test Device”are offered for sale in the United States directly to consumers to self-test at home or outside of a healthcare setting without marketing approval, clearance, or authorization from FDA.The agency advised to stop selling the device.Firm is ordered to take immediate action to address the violations. FDA advised the firm to review its websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that they do not make claims that adulterate or misbrand the products in violation of the Act and FDA said-Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.