FDA 483 - Rite-Kem Incorporated - September 12, 2024

An FDA inspection of Rite-Kem Incorporated, an OTC drug manufacturer in Tupelo, MS, revealed widespread deficiencies in their manufacturing operations. The firm failed to conduct essential product and component testing, lacked critical written procedures for cleaning, process controls, and complaint handling, and maintained incomplete batch and distribution records. These significant issues indicate a severe lack of adherence to current good manufacturing practices, raising concerns about the quality, purity, and identity of their distributed OTC drug products.