Puremedy Inc. – FDA 483, Jul 26, 2024

An FDA inspection of Puremedy Inc., a manufacturer of homeopathic drug products, revealed significant deficiencies across its production, quality, and laboratory systems. The firm failed to establish written procedures for process controls, quality control unit responsibilities, and lacked essential testing for finished products and raw materials. Several critical observations, including lack of process validation, stability data, and equipment calibration, were repeat findings, highlighting persistent non-compliance with manufacturing regulations.