FDA 483 - LW Scientific, Inc. - October 19, 2021

An FDA inspection of LW Scientific, Inc. in Lawrenceville, GA, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for corrective and preventive actions, complaint handling, personnel training, supplier management, device history records, acceptance activities, and document control. These issues indicate a systemic breakdown in maintaining a compliant quality system for medical device manufacturing.