FDA 483 - Nature Major Inc - February 28, 2020

Nature Major Inc, a medical device relabeler in New York, NY, was inspected by the FDA from February 26-28, 2020. The inspection revealed significant deficiencies in the firm's quality system, specifically the lack of established written procedures for medical device reporting, handling consumer complaints, and implementing corrective and preventive actions. These observations indicate a fundamental absence of critical quality control processes.