FDA 483 - Thrive Health and Wellness, LLC, dba Thrive Health Solutions - April 03, 2025

From March 25 to April 3, 2025, an FDA inspection of Thrive Health and Wellness, LLC, dba Thrive Health Solutions, a sterile and non-sterile drug producer in Englewood, CO, revealed six observations.

The firm lacks a certified ISO-5 classified area for sterile compounding, filling subcutaneous injection syringes (Semaglutide, Tirzepatide, Cyanocobalamin, Lipoboost, Sermorelin) on a benchtop in an unclassified room. Beyond-use dates (BUDs) for repackaged syringes were identical to original vials, despite the unclassified environment.

Operators involved in sterile syringe repackaging have never conducted media fills to simulate aseptic production. The production area, also serving as an office, is cluttered with supplies, office equipment, and cardboard boxes, and has a carpeted floor, making cleaning difficult.

Personnel engaged in aseptic processing were observed wearing non-sterile gloves and lacked appropriate sterile gowning, head covers, or masks. Disinfection practices were insufficient; sporicidal agents were not used or available, non-sterile wipes were used for cleaning, and work surfaces were not disinfected prior to packaging. These conditions indicate potential contamination risks for sterile drug products.