FDA 483 - Baxter Healthcare S.A. - May 31, 2018

An FDA QSIT level II surveillance inspection was conducted at Baxter Healthcare S.A. in Haina, Dominican Republic, from May 28 to May 31, 2018. The inspection focused on the manufacturing of Class II sterile medical tubing sets, including Continu-Flo and Buretrol product lines, and was part of the FDA's FY 2018 work plan for medical device manufacturers. The regulatory framework for this inspection was C.P. 7382.845, Inspection of Medical Device Manufacturers. The inspection comprehensively reviewed several critical quality system subsystems, including Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. Records examined included the Quality Manual, SOPs, management review meeting minutes, internal audits, design transfer and change control, CAPAs, non-conformances, customer complaints, medical device reports, validation studies, and sterilization records. Notably, at the conclusion of the four-day inspection, no FDA-483 observations were issued to Baxter Healthcare S.A. This signifies that the facility was found to be operating in compliance with relevant regulatory requirements for medical device manufacturing. Consequently, no specific regulatory actions or required corrective measures were mandated by the FDA as a direct result of this inspection.