FDA 483 - VIANT PUERTO RICO, INC - December 19, 2025

VIANT PUERTO RICO, INC, a combination product manufacturer in Vega Baja, PR, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in data integrity, inadequate equipment design and validation, non-adherence to production and process control procedures, and issues with supplier qualification. These findings indicate a need for comprehensive improvements across several critical operational areas.