FDA 483 - Creation Technologies Ltd - April 14, 2023

Creation Technologies Ltd in Burnaby, a contract manufacturer, received a Form FDA 483 with three observations following an inspection from April 10-14, 2023. The observations primarily concern deficiencies in document control, corrective and preventive action (CAPA) procedures, and procedures for ensuring purchased products and services conform to requirements. These issues indicate a need for improved quality system controls.