Lynn Medical Instrument Co. – FDA 483, Jul 31, 2026

An FDA inspection of Lynn Medical Instrument Co. revealed significant deficiencies across its quality management system, particularly concerning risk management, complaint handling, and supplier controls. The firm failed to maintain adequate records for various critical processes, including risk management activities, non-reportable corrections, and supplier evaluations. Additionally, the overall quality management system was found to be ineffective, with procedures not being executed and software used for complaint handling remaining unvalidated.