FDA 483 - RADIANCE BEAUTY & WELLNESS INC. - April 28, 2023

RADIANCE BEAUTY & WELLNESS INC. in Chatsworth, CA, was inspected and found to have significant deficiencies across its quality control unit, laboratory controls, and batch record management. The firm failed to establish a proper QCU, conduct essential raw material and in-process testing, maintain adequate records for rejected materials and manufacturing processes, and implement a stability program for its OTC drug products. These issues indicate a severe lack of adherence to GMP practices, posing a risk to product quality and patient safety.