FDA WARNING_LETTER - Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. - April 18, 2024

The FDA issued a Warning Letter to Ms. Ross on April 18, 2024 (WL 2643) regarding drug listing information for multiple products including Relief Balm, Sports Balm, Womens Relief Balm, Womens Sports Balm, and Hand Sanitizer (NDCs 70146-000 to 70146-012).

The firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p). The drugs are also misbranded under section 502(o), making their introduction into interstate commerce prohibited under section 301(a).

Violations include incorrect manufacturer information: Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. (DUNS 650517704) is listed as the manufacturer, but confirmed not to be involved in manufacturing. Despite requests to deregister and delist, no corrections have been made. Additional listing errors include incorrect dosage forms, mismatched active ingredient strengths, missing active ingredients, and incorrect label images, violating 21 CFR 207.49(a)(4), (6), and (15)(ii)(B).

The FDA relies on accurate listing for inspections, supply chain security, and post-market surveillance. The firm must investigate and correct all violations, including other products, within