Thrive Health Solutions — FDA Warning Letter (February 9, 2026)

From March 25, 2025, to April 3, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Thrive Health and Wellness, LLC dba Thrive Health Solutions, located at 88 Inverness Circle E Ste A-204, Englewood, CO 80112. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. Your personnel were observed conducting aseptic operations outside of a certified ISO 5 area. More specifically, your personnel filled sterile drug products into syringes on a benchtop table located in an unclassified room that shared the workspace with a blood sample centrifuge. These drug products were not intended for immediate administration to patients but were distributed for future administration outside your facility.

2. Your personnel performing sterile operations have never performed media fills. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

3. Your aseptic processing and surrounding areas had difficult to clean equipment and surfaces. For example, your entire facility flooring was covered with carpet.

4. Your personnel engaged in aseptic processing while wearing non-sterile gloves and with exposed hair and skin.

5. Your firm failed to use a sporicidal agent as part of your disinfection program for the aseptic processing area and used non-sterile wipes to clean within the area where drug products were filled into syringes.