WARNING LETTER
Zen Enterprises LLC
MARCS-CMS 678407 —
April 18, 2024
Product:
Drugs
Recipient:
Recipient Name
David Makima
Zen Enterprises LLC
9061 W. Sahara Ste 105
Las Vegas
,
NV
98117-5797
United States
Registration@fdaimports.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
April 18, 2024
RE: WL 2644
Dear Mr. Makima:
This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug products, Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Sycuan Casino Resort Hand Sanitizer, NDC 73048-003.
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Your firm has not fulfilled its listing obligations under section 510(j) of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, the drugs stated above are not properly listed with FDA, causing them to be misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
Registration and Drug Listing Violations
Section 510(j) of the FD&C Act, 21 U.S.C 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. Drug listing submissions must include the name and Unique Facility Identifier of the establishment where the registrant who lists the drug manufactures it and the type of operation performed on the drug at that establishment as required under section 510(j)(1)(c) of the FD&C Act, 21 U.S.C. 360(j)(1)(c), and 21 CFR 207.49(a)(12)(i). Furthermore, in accordance with 21 CFR 207.49(a)(12)(ii), the listing file must include the name and Unique Facility Identifier of every other establishment where manufacturing is performed for the drug and the type of operation performed at each such establishment. In the listing files submitted to FDA for Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Sycuan Casino Resort Hand Sanitizer, NDC 73048-003, the manufacturer referenced under the establishment section of the listing SPL files is identified as Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd., (DUNS 650517704). However, in accordance with the response provided on December 15, 2022 to the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) to their 704(a)(4) records request, it was confirmed that Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. is not currently involved in the manufacturing of the drugs mentioned above. Thus, Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. should not be registered with FDA as a manufacturer, nor should this firm be included as the manufacturer under the establishment sections of any drug listing files. To date, no updates have been made to the listing files to correct the manufacturer that is referenced.
Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, the drugs Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Sycuan Casino Resort Hand Sanitizer, NDC 73048-003 are not properly listed with FDA, causing them to be misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.
We note that this warning letter only addresses registration and listing issues associated with your products included above. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance. It is also your responsibility to correct any listing deficiencies with all other products distributed by your firm.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. 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.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number 2644 on all correspondence.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
_________________________
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On December 4, 2023, we sent you a drug listing deficiency letter notification describing the observed listing deficiencies in the information you submitted. On January 18, 2024, we sent you a data removal email notification informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your product’s data removal from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted by your firm to FDA. If this information has changed, it is your responsibility to update this within 30 days of any change, under 21 CFR 207.33(c).
Content current as of:
04/23/2024
Regulated Product(s)
Drugs