FDA WARNING_LETTER - Zen Enterprises LLC - April 23, 2024

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The FDA issued a Warning Letter to Mr. Makima regarding drug listing deficiencies 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 firm failed to fulfill drug listing obligations under section 510(j) of the FD&C Act, a prohibited act under section 301(p). These drugs are also misbranded under section 502(o), with their introduction into interstate commerce prohibited by section 301(a).

Specifically, the listing files identified Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. as the manufacturer, but a December 15, 2022, response confirmed this entity is not involved in manufacturing these drugs. No updates have been made to correct this, violating 21 U.S.C. 360(j)(1)(c) and 21 CFR 207.49(a)(12)(i)-(ii).

The FDA previously sent a deficiency letter on December 4, 2023, and a data removal notification on January 18, 2024, leading to the products' removal from the Online

Company: Zen Enterprises LLC
Inspection Date: April 23, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Tina Smith (Director)

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ID · cb52d5e6-4bbb-4f22-a023-47b905caeef1

Violation Codes9

21 U.S.C. 331(a)21 U.S.C. 360(j)21 U.S.C. 331(p)21 U.S.C. 352(o)21 CFR 20721 CFR 207.49(a)(12)(i)21 CFR 207.49(a)(12)(ii)21 CFR 207.57(b)(2)21 CFR 207.33(c)

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