FDA 483 - Machida Endoscope Co., Ltd. - December 07, 2023

Machida Endoscope Co., Ltd. in Abiko, Chiba, Japan, was inspected by the FDA from December 4-7, 2023. The inspection revealed that the firm failed to adequately establish procedures for the review and disposition of nonconforming products. Specifically, the firm did not document the justification for the use of a nonconforming Flexible Nasopharyngo Laryngoscope.