FDA 483 - Flextronics Romania Srl - May 11, 2017

An FDA inspection of Flextronics Romania Srl, a manufacturer in Timisoara, Romania, identified one significant observation. The firm's procedures for accepting incoming product were found to be inadequately established. Specifically, the company failed to inspect incoming materials, such as Luer Lock Connectors and PVC Tubes, using the correct sample sizes as required by their own Station Instruction Card and ANSI/ASQC Z1.4 standards.