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  5. AG Essence, Inc. - 678344 - 06/14/2024
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WARNING LETTER

AG Essence, Inc. MARCS-CMS 678344 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Belkis Wingfield
Recipient Title
President
AG Essence, Inc.

5350 Lewis Rd Ste E
Sandston, VA 23150
United States

Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS# 678344

June 14, 2024

Dear Belkis Wingfield:

During an inspection of your firm located at 5350 Lewis Rd, Ste E, Sandston, VA 23150 between January 9, 2024, and January 22, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of the Banda-SiL Silver Wound Care Gel and Banda-Sil Silver Liquid Gel Spray. We note that FDA has had prior communications with your firm about these products.

From June 3 to June 11, 2019, an inspection of the firm identified violations leading to a Regulatory Meeting with FDA representatives on April 27, 2020. During the discussion with the firm in the Regulatory Meeting on April 27, 2020, FDA representatives informed your firm that your products require premarket review. This regulatory information was also communicated to your firm in a follow-up meeting with the FDA held July 20, 2020, and in a follow-up letter issued to your firm on February 5, 2021. In a letter dated February 17, 2021, your firm indicated that it would cease marketing the products by March 1, 2021, if a premarket notification (510(k)) was not submitted for the products by that date. From the time of your firm’s February 17, 2021, letter to date, your firm has not submitted a 510(k) for FDA’s review of the products.

Our inspection and review of the available information revealed that your firm continues to market these products without marketing authorization. Wound dressings containing certain chemicals or other ingredients, including antimicrobials (e.g., silver), and wound dressings containing animal and certain naturally-derived materials (e.g., chitosan) include several risks which necessitate the premarket review of these products prior to marketing. These risks include adverse tissue reaction, immunological reaction, transmission of pathogens and parasites, toxicity, delayed wound healing, incompatibilities with other therapies, contribution to the spread of antimicrobial resistance, infection, microbial growth within the product, product degradation during stated shelf storage, and negatively impacting the skin microbiota in the periwound area resulting in impaired wound healing. Wound dressings with this technology that are intended to cover and protect or maintain the moisture balance of a wound are generally regulated by CDRH, categorized within FDA product code FRO (dressing, wound, drug), and require submission of a 510(k) for FDA review. However, please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification or jurisdiction of the product. For example, your firm appears to be making claims for the Banda-SiL products that go beyond the types of claims appropriate for wound dressings categorized under the FRO product code. An example of such claims for the Banda-SiL products is the following provided on your website (https://bandasilwoundcare.com/): “Banda-SiL's chelated silver, derived from natural sources, prevents infection, stimulates wound healing, and promotes skin matrix repair.” If you intend to continue making such claims for these products, we note that these products may be regulated by the Center for Drug Evaluation and Research (CDER) and require an approved new drug application, among other requirements.1

However, assuming that the claims for these products would be consistent with wound care products regulated by CDRH, these products would be adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products would also be 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 products into interstate commerce for commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a product requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)). The kind of information that your firm needs to submit in order to obtain approval or clearance for the products is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.

Additionally, assuming that the claims for these products would be consistent with wound care products regulated by CDRH, your products would be in violation of the Act in other respects as well. For example, based on the available information, your products would be in violation of unique device identifier (UDI) requirements, FDA’s Global Unique Device Identification Database (GUDID) reporting requirements, and device registration and listing requirements. We discuss these further below.

UDI Labeling
Based on the inspection, your products would also be misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the products was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and package bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels and packages of the Banda-SiL products do not bear such a UDI.

Specifically, based on the available information, including the information on the Banda-SiL products collected during our inspection, the Banda-SiL products do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, there is no UDI presented in easily readable plain-text (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology (see 21 CFR 801.40(a)(2)).

Submitting Required Information to GUDID
In addition, the Banda-SiL products would be misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these products. In particular, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to the Banda-SiL products with the intent that the products will be commercially distributed without any subsequent replacement or modification of the label. AG Essence, Inc. is therefore a “labeler” within the meaning of 21 CFR 830.3, and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these products.

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Registration & Listing
Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act, 21 U.S.C. § 360(p)) during the period beginning October 1st and ending December 31st of each year. Our inspection and records indicate that your firm’s medical device registration has been inactive since 2022 and your firm has not fulfilled annual device registration and listing requirements for fiscal year 2024.

Therefore, all of your firm’s devices would be misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).2

We request that your firm cease any activities that result in the misbranding or adulteration of the products, such as their commercial distribution without complying with FDA requirements as discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen 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 the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those 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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Emma Schaefer, Acting Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov. Refer to CMS 678344 when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan, Compliance Officer at 410-779-5134 or sean.moynihan@fda.hhs.gov.

We received a response, dated February 12, 2024, along with two updated responses dated April 29, 2024, and May 29, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. The responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Joseph S. Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
  Division 1 - East

/S/

Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Surgical and Infection Control
  Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

_____________________

1 You have asserted that your Banda-SiL products are homeopathic drugs. Note that absent a determination that a homeopathic drug product is not a “new drug” under section 201(p) of the FD&C Act, such a homeopathic drug product is subject to the premarket approval requirements in section 505 of the FD&C Act.

2 For purposes of this letter, “devices” include combination products under section 503(g) of the Act, 21 U.S.C. § 353(g), and 21 CFR 3.2(e) that contain a device constituent part and that are regulated by CDRH.

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