FDA 483 - Konica Minolta, Inc. - April 05, 2023

Konica Minolta, Inc. in Hachioji, Tokyo, Japan, a specification developer, was cited for significant deficiencies in its medical device design control processes. The inspection revealed inadequate procedures for design review, insufficient documentation of design verification results in the design history file, and a lack of documentation for design validation results. These issues indicate a systemic breakdown in ensuring device safety and effectiveness through proper design controls.