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 the firm's quality system, primarily due to the lack of established written procedures for critical processes such as complaint handling, purchase controls, medical device reporting (MDR), and corrective and preventive actions (CAPA). Additionally, the firm failed to submit required information to the Global Unique Device Identification Database for its Class II medical device.