FDA 483 - Advanced RX Pharmacy of Tennessee LLC - September 06, 2024

Advanced RX Pharmacy of Tennessee LLC, a drug repacker/relabeler in Nashville, TN, was cited for significant deficiencies in its quality control unit during an FDA inspection. The firm failed to ensure drug products were manufactured in accordance with current good manufacturing practices (cGMP), evidenced by inadequate reviews of incoming products, deficient batch records, and a lack of written procedures for quality events, investigations, and change control. These issues indicate a systemic breakdown in quality assurance processes.