Matthew 7:25 Inc dba Thrive Pharmacy
FDA issued a warning letter to Matthew 7:25 Inc dba Thrive Pharmacy (Jacksonville, FL) after a December 2019 inspection found the compounding pharmacy failed to meet section 503A conditions, including compounding drug products without valid patient-specific prescriptions (e.g., phentermine 37.5 mg capsules for office stock). FDA laboratory analysis confirmed that three buprenorphine/naloxone troche products were subpotent relative to their labeled concentrations, rendering them adulterated and misbranded under the FDCA. The pharmacy had already initiated a voluntary recall of the affected troches in March 2020, but FDA found corrective actions incomplete and warned that failure to address violations could result in seizure or injunction.
Flagged claims (3)
your Buprexone Banana Cream 6-0.6 mg Troche, Buprenorphine Watermelon 8 mg Troche, and Buprenorphine Black Cherry 2 mg Troche drug products contained 85.7% (80.2% for Naloxone), 92.5%, and 89.4%, respectively, of the labeled concentrations of Buprenorphine
your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced, including phentermine 37.5 mg capsules
your firm compounded drug products that might be considered essentially copies of commercially available drug products (e.g., phentermine hydrochloride 37.5 mg capsules and buprenorphine hydrochloride 8 mg troches)
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. A third-party consultant with relevant drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
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