FDA WARNING_LETTER - Thrive Health and Wellness, LLC, dba Thrive Health Solutions - April 03, 2025

The FDA issued a warning letter to Thrive Health and Wellness, LLC (doing business as Thrive Health Solutions) following an inspection of its Englewood, Colorado, facility conducted from March 25 to April 3, 2025. The agency identified significant safety violations concerning the production of sterile drug products, which posed potential risks to patient health. The primary issues involved producing drugs under insanitary conditions. Specifically, investigators observed staff filling syringes on a standard table in an unclassified room featuring carpeted floors and a blood centrifuge, rather than in a controlled, sterile environment. Personnel lacked proper sterility validation training, used non-sterile gloves and wipes, and failed to wear adequate protective clothing. Additionally, the company was repackaging medications such as Tirzepatide and NAD+ without necessary FDA approvals. These products were also considered misbranded because their labels lacked adequate directions for safe use by consumers. These practices violate the Federal Food, Drug, and Cosmetic Act regarding drug purity, safety, and labeling standards. Although Thrive Health Solutions ceased repackaging operations and initiated a voluntary recall in May 2025, the FDA requires formal corrective actions. The company must submit a written response within 15 working days detailing steps taken to address these violations. Furthermore, if the firm intends to resume sterile drug production in the future, it must notify the FDA 15 days prior to restarting and provide documentation proving that all safety deficiencies have been fully resolved.