FDA 483 - Boca Dental Supply LLC - July 22, 2019

An FDA inspection of Boca Dental Supply LLC, an initial importer in Boca Raton, FL, revealed significant deficiencies in its quality system. The firm lacked adequate procedures for complaint handling, Medical Device Reporting (MDR), corrective and preventive actions, storage area control, and finished device distribution. These observations indicate a systemic failure to establish and implement essential quality system processes.