483
VIANT PUERTO RICO, INCFDA 483 - VIANT PUERTO RICO, INC - December 19, 2025
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Record Details
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.
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ID · ff17c58e-b665-460d-8993-bbc2150b6bf4