FDA 483 - G. Dundas Co Inc - August 08, 2019

G. Dundas Co., Inc., a manufacturer of Class 2 medical devices in Black Diamond, WA, was inspected and cited for significant deficiencies in its quality system. Observations included a lack of approval signatures on critical Standard Operating Procedures, inadequate document control procedures regarding Engineering Change Orders, and insufficient documentation of training for individuals conducting quality self-audits. These issues indicate a systemic failure in maintaining proper documentation and quality assurance processes.