FDA WARNING_LETTER - Matthew 7:25 Inc dba Thrive Pharmacy - December 20, 2019

The FDA issued a Warning Letter to Matthew 7:25, Inc. dba Thrive Pharmacy, following an inspection from December 12-20, 2019. The inspection revealed that drug products produced by the firm failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, and noted deficiencies in drug production practices.

Violations included compounding drug products, such as phentermine 37.5 mg capsules, without valid prescriptions for individually-identified patients, making them ineligible for 503A exemptions. These "ineligible drug products" were deemed adulterated under Section 501(a)(2)(B) due to significant CGMP violations. Specific CGMP failures included: lack of laboratory determination of conformance to final specifications (21 CFR 211.165(a)), inadequate stability testing programs (21 CFR 211.166(a)), and insufficient written procedures for production and process control (21 CFR 211.100(a)).

FDA analysis of Buprexone Banana Cream 6-0.6 mg Troche, Buprenorphine Watermelon 8 mg Troche, and Buprenorphine Black Cherry 2 mg Troche samples found them subpotent, containing 85.7% (80.2% for Naloxone), 92.5%, and 89