FDA 483 - AmWiner & Raphe Holdings LLC - August 07, 2024

AmWiner & Raphe Holdings LLC in Dallas, TX, was inspected and cited for significant deficiencies in its quality control, manufacturing processes, and laboratory operations. The firm failed to conduct essential testing for raw materials and finished drug products, lacked process validation and stability programs, and had issues with equipment maintenance and calibration. These issues indicate a severe lack of adherence to good manufacturing practices for OTC drug products.