FDA 483 - Vantive Manufacturing (Thailand) Company - December 03, 2024

Baxter Manufacturing Thailand Co., Ltd. in Pluak Daeng, Thailand, was inspected and cited for significant deficiencies across its quality control and manufacturing operations. The inspection revealed severe data integrity issues in laboratory records, inadequate investigations into product complaints involving microbial contamination and leakage, and deficiencies in sterile product visual inspection and environmental monitoring. These observations indicate a systemic failure to adhere to established quality standards and procedures for drug product manufacturing.