FDA 483 - The Side Lyer Company LLC - March 12, 2026

The FDA inspected The Side lyer Company LLC in Orlando, FL, a specification developer, and found significant deficiencies across its quality management system. Observations included failures in design change control, risk management, record keeping for management reviews and internal audits, purchasing controls, final product acceptance, and personnel training. These issues indicate a broad lack of adherence to regulatory requirements for medical device quality systems.