FDA 483 - Cognivue Inc. - June 04, 2019

Cognivue Inc., a medical device manufacturer in Victor, NY, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including inadequate software validation, design change procedures, supplier management, CAPA processes, nonconforming product control, device master records, and device history records. These issues indicate a systemic lack of established and followed procedures for critical quality system elements.