Medify Air LLC – FDA 483, Apr 23, 2026

Medify Air LLC in Boca Raton, FL, a specification developer of medical devices, was cited with four observations during an FDA inspection. The firm failed to document its quality management system, establish and maintain medical device files and design and development files for its air cleaners, and develop written procedures for medical device reporting (MDRs). These findings indicate significant deficiencies in the firm's quality system and regulatory compliance.