Thrive Health and Wellness, LLC dba Thrive Health Solutions

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.

FDA issued a Form FDA 483 to your firm on April 3, 2025. FDA acknowledges receipt of your facility’s response, dated April 22, 2025. FDA further acknowledges that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. FDA also acknowledges that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

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.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

You do not have any FDA-approved applications on file for the drug products that you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL.2 These products are unapproved new drugs under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)]. A new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)].3

The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.4 Accordingly, these drug products are misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FDCA. It is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

We have reviewed your facility’s response to the Form FDA 483. We acknowledge that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. We also acknowledge that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance.

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

If you decide to resume operations to produce sterile drug products not intended for immediate use, you should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 714891) and include a subject line that clearly identifies the submission as a Response to Warning Letter.