FDA 483 - Wisdom Medical Technologies - August 19, 2019

An FDA inspection of Wisdom Medical Technologies in Oswego, IL, revealed significant issues across its manufacturing operations for Class IV laser systems and fiber optic accessories. The firm failed to meet electronic product radiation control standards, including deficiencies in product certification, labeling, quality control testing, and product reporting. Additionally, the inspection identified inadequate quality system procedures related to MDR complaint investigations, acceptance activities, corrective and preventive actions, and supplier management.