FDA 483 - VIANT PUERTO RICO, INC - May 02, 2025

VIANT PUERTO RICO, INC in Vega Baja, PR, was issued a Form 483 with two observations following an inspection from April 28 to May 2, 2025. The inspection revealed significant deficiencies in the firm's quality system, including failures to thoroughly review discrepancies, document line clearances, and implement corrective and preventive actions. Additionally, the quality control unit lacked adequate procedures and documentation for managing change controls related to facility construction and new equipment.