Loading…
Ehy Holdings, LLC failed to properly register and list ten drug products with the FDA, including nicotine transdermal patches, wart removers, and various topical creams, in violation of section 510(j) of the Federal Food, Drug, and Cosmetic Act. The company did not provide required listing information such as the name and Unique Facility Identifier of establishments where the drugs were manufactured and the types of operations performed at each facility. These registration and listing failures rendered the drugs misbranded and prohibited their introduction into interstate commerce under section 301(a) of the FD&C Act.