Thrive Health and Wellness, LLC dba Thrive Health Solutions — FDA Warning Letter Findings

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…

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

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.

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

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.