FDA 483 - Hamilton Medical, Inc. - May 17, 2019

This FDA Form 483 was issued to Hamilton Medical, Inc. in Reno, NV, an importer and servicer of Class 2 ventilators, following an inspection that revealed significant deficiencies in their quality system. The firm failed to establish, document, or implement fundamental procedures for complaint handling, corrective and preventive actions, quality audits, and management review. These widespread procedural failures indicate a severely underdeveloped quality system.