FDA 483 - Medin Technologies, Inc. - February 16, 2022

Medin Technologies, Inc. in Totowa, NJ, a medical device manufacturer, was inspected by the FDA from December 2021 to February 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for corrective and preventive actions, complaint handling, internal audits, management reviews, supplier management, training, and document control. These findings indicate a systemic failure to maintain an effective quality system.