WARNING LETTER

Thrive Health and Wellness, LLC dba Thrive Health Solutions MARCS-CMS 714891 — February 09, 2026

Delivery Method:: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:: Drugs

Recipient:: Recipient Name

Doug Hatch; Recipient Title

Owner; Thrive Health and Wellness, LLC dba Thrive Health Solutions; 88 Inverness Circle East, Ste A-204
Englewood, CO 80112-5521
United States

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

WARNING LETTER
WL # 714891

February 9, 2026

Dear Mr. Hatch:

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).

A. Compounded Drug Products Under the 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

B. Violations of the FDCA

Adulterated Drug Products

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.

Unapproved New Drug Products

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 505
of 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

Misbranded Drug Products

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.

C. Corrective Actions

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.

D. Conclusion

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.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of sterile drug products not intended for immediate use. If you intend to resume production of sterile drug products not intended for immediate use in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future.

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.

Sincerely,
/S/

Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research

______________________

1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.

2 The specific products repackaged by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

3 Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period.

4 The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).