FDA EIR - Terumo BCT Vietnam Co. Ltd. - August 15, 2019

Terumo BCT Vietnam Co. Ltd. underwent an FDA inspection from August 12 to August 15, 2019, in Long Thanh, Dong Nai, Vietnam. This was the facility's first FDA inspection since becoming operational in 2013. The inspection was a pre-announced QSIT Level 2 review, conducted under CPGM 7382.845 for medical device manufacturers, specifically for Class 2 medical devices, disposable kits for the Trima Accel Automated Blood Collection System, destined for the US market. The comprehensive assessment covered all quality system areas, including management controls, corrective and preventive actions, production, process controls, records, facilities, and material controls. Significantly, the inspection concluded with no adverse observations, and consequently, no FDA-483 was issued. This indicates that the facility's operations met regulatory expectations at the time of the inspection. While the document referenced past issues, such as deficiencies identified during a supplier audit of Terumo BCT in Lakewood, CO, requiring a Supplier Corrective Action, and a prior market withdrawal related to excess residue in certain product lots (which the firm addressed with a Health Hazard Analysis and retrospective validation), these were not cited as new violations during the August 2019 inspection. As no objectionable conditions were found, no immediate regulatory actions were mandated by the FDA as a direct result of this specific inspection.