FDA 483 - Jia Ding Precision Industry Co., Ltd. - August 22, 2018

Jia Ding Precision Industry Co., Ltd. in Taichung City, Taiwan, was inspected by the FDA from August 20-22, 2018. The inspection revealed that the firm's procedures for identifying products during all stages of production were not adequately established. Specifically, lot numbers for inspected devices were not documented during in-process monitoring, which prevented traceability to finished device lots.