FDA EIR - Becton Dickinson Medical (Singapore) - October 25, 2018

The FDA conducted a comprehensive Level 2 Quality System Inspection Technique (QSIT) inspection of Becton Dickinson Medical (Singapore), Pte. Ltd. from October 22 to October 25, 2018. The inspection was part of routine surveillance under the Center for Devices and Radiological Health's (CDRH) 2019 work plan, guided by Compliance Programs 7382.845 for medical device manufacturers.

Becton Dickinson Medical (Singapore) manufactures Class 2 luer lock syringes and safety needles. The inspection focused on four major medical device subsystems: Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls (P&PC). Additional areas reviewed included validation, sterilization, and Purchasing Management/Supplier Controls. The inspection also evaluated the Records, Documents, and Change Controls subsystem.

No deficiencies were identified during the previous inspection in September 2015, which was also a Level 2 surveillance inspection. The 2015 inspection did not cover Design Controls and had limited coverage of P&PC and CAPA. The current inspection aimed to address these areas comprehensively.

The inspection did not result in any citations on Form FDA 483, indicating no significant violations or issues were found. The firm is expected to maintain compliance with FDA regulations and ensure ongoing adherence to quality management practices. The inspection findings will support the FDA's continued oversight and assurance of the safety and effectiveness of the medical devices produced by Becton Dickinson Medical (Singapore).