FDA WARNING_LETTER - Las Villas Health Care LLC dba Villas Health - August 31, 2025

The FDA issued a warning letter to Villas Health on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Villas Health was offering compounded drug products, including semaglutide and sildenafil, with claims that were deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded drugs were equivalent to FDA-approved products, which they are not, thus misbranding the products.

The main violations identified include the misbranding of compounded semaglutide and sildenafil products due to misleading advertising and promotional claims. This constitutes a violation of section 301(a) of the FDCA, which prohibits the introduction of misbranded drugs into interstate commerce.

The FDA requires Villas Health to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must respond within 15 working days with a written plan detailing the steps taken to address the violations and prevent future occurrences. Failure to comply may result in legal actions such as seizure or injunction. Villas Health is also advised to provide reasoning and supporting information if they believe their products are not in violation of the FDCA. Correspondence should be directed to the Office of Compounding Quality and Compliance within the FDA.