FDA EIR - baxter healthcare s.a. / - May 31, 2018

An FDA QSIT level II surveillance inspection of Baxter Healthcare S.A., a foreign manufacturer of Class II medical tubing sets located in Haina, Dominican Republic, was conducted from May 28 to May 31, 2018. This routine inspection, part of the FY 2018 work plan for medical device manufacturers, adhered to the regulatory framework of C.P. 7382.845, 'Inspection of Medical Device Manufacturers.' The inspection focused on various product lines, including Continu-Flo and Buretrol infusion sets, and evaluated subsystems such as Management Controls, Design Controls, Corrective and Preventive Actions, and Production and Process Controls. Notably, no FDA-483 observations, indicating significant violations or issues, were issued at the conclusion of the inspection. As a result, no specific regulatory actions were required from Baxter Healthcare S.A. directly stemming from this inspection. The facility is registered with the U.S. FDA and distributes its finished devices in interstate commerce, primarily to U.S. distribution centers after sterilization performed at other sites.