FDA 483 - Revive Rx LLC dba Revive Rx Pharmacy - March 27, 2026

Revive Rx LLC, operating as Revive Rx Pharmacy, underwent an FDA inspection at its Houston, Texas, facility from March 9 to March 27, 2026. The resulting Form 483 highlights several significant concerns regarding the firm"s sterile and non-sterile drug production processes, many of which are repeat observations. Primary violations include persistent microbial contamination—specifically mold and spore-forming bacteria—within sterile ISO 5 and ISO 7 areas. The firm failed to adequately identify these organisms or implement effective cleaning and disinfection protocols. Additionally, the FDA noted that smoke studies were only performed under static conditions, failing to prove that sterile airflow is maintained during actual production activities. Further issues included inadequate personnel monitoring, with multiple staff members and supervisors failing gowning and media fill qualifications. The inspection also observed sterile products being exposed to inferior air quality during transfers between cleanrooms and the use of unvalidated sterilization methods for lyophilization equipment. These observations were issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which identifies conditions that may cause drug products to become contaminated or injurious to health. Revive Rx is expected to respond to these findings with a comprehensive corrective action plan to address the systemic failures in their quality control and aseptic processing environments.