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Talk to a SpecialistTalk to a SpecialistAnne's Daye Ltd dba Tampon Innovations manufactured CBD-coated tampons and vaginal microbiome screening kits without required FDA premarket approval (PMA) or investigational device exemption (IDE), rendering the products adulterated and misbranded medical devices. An FDA inspection conducted in Bulgaria from July 8-11, 2024, identified violations including the commercial distribution of the CBD Daye Tampon without proper marketing authorization and undisclosed major changes to the device. The company's website marketing of these unapproved devices and their failure to obtain required premarket authorization constituted the primary compliance failures.