FDA 483 - Zyno Electric & Machinery Ltd, Shanghai - August 16, 2018

An FDA inspection of Zyno Electric & Machinery Ltd in Shanghai, China, a manufacturer of infusion pumps, identified one significant observation. The firm failed to adequately establish procedures for controlling environmental conditions, specifically regarding the prevention and control of Electrostatic Discharge (ESD). This included issues such as missing ESD ground wire systems on workbenches and storage, and improper use of wrist straps by personnel.