FDA 483 - Mirac LLC - February 17, 2026

Mirac LLC, a medical device manufacturer in Dayton, OH, received a Form 483 with nine observations following an FDA inspection. The inspection revealed significant deficiencies across its quality management system, including inadequate procedures for nonconforming product control, process validation, risk management, internal audits, supplier control, and document control. These issues indicate a systemic failure to ensure product conformity and maintain an effective quality system.