FDA 483 - McRoberts B.V. - August 28, 2019

McRoberts B.V., a medical device manufacturer in The Hague, Netherlands, was inspected by the FDA from August 26-28, 2019. The inspection revealed significant deficiencies across its quality management system, including inadequate procedures for design validation, software validation, risk analysis, design review, CAPA, training, supplier controls, and organizational structure. These issues indicate a systemic lack of adherence to established quality system requirements for medical devices.