FDA WARNING_LETTER - Ehy Holdings, LLC - February 06, 2024

The FDA issued a Warning Letter to Jabez Liu on February 2, 2024 (WL #2642) regarding drug listing violations for ten products, including Nicotine Transdermal Patches, Wart Remover, and various creams. The firm failed to fulfill its listing obligations under section 510(j) of the FD&C Act, making it a prohibited act under section 301(p). Additionally, these drugs are misbranded under section 502(o), and their introduction into interstate commerce is prohibited under section 301(a).

The core violation is that the submitted listing files incorrectly identified Ehy Holdings, LLC (DUNS 117322715) as the manufacturer. A June 27, 2023, communication revealed Ehy Holdings, LLC is not involved in manufacturing these drugs for U.S. distribution or import. Consequently, the listings do not reference a correct or active registered manufacturing establishment, and no updates were provided, violating 21 U.S.C. 360(j)(1)(c) and 21 CFR 207.49(a)(12)(i) and (ii).

The FDA emphasizes that accurate registration and listing are crucial for patient safety, inspections, supply chain security, and post-market surveillance. The firm must investigate and correct all violations, including other products, within