FDA 483 - MIDWAY MEDICAL - January 15, 2026

MIDWAY MEDICAL, a specification developer in Bloomington, IL, was inspected and received a Form FDA-483 with five observations. The inspection revealed significant deficiencies in their quality system, primarily concerning the lack of established written procedures for complaint handling, purchase controls, MDR reporting, and corrective and preventive actions. Additionally, the firm failed to submit required information to the Global Unique Device Identification Database for their Class II medical device.