FDA 483 - Teleflex Medical Europe Ltd - May 05, 2017

Teleflex Medical Europe Ltd in Athlone, Ireland, was inspected from May 2-5, 2017, revealing inadequacies in their design change procedures. The firm failed to adequately establish procedures for design changes, specifically concerning documentation and cross-referencing between various internal control documents. This indicates a moderate severity issue related to their quality system for medical device development.