FDA 483 - Laboratorios Dentales De Zona Franca, S.A. - January 30, 2020

An FDA inspection of Laboratorios Dentales De Zona Franca, S.A., a medical device manufacturer in San Isidro del Guarco, Costa Rica, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, product acceptance, complaint handling, nonconforming product control, process validation, document control, and supplier evaluation. These issues indicate a broad lack of control over critical manufacturing and quality processes for dental devices.