FDA 483 - ICU Medical de Mexico, S.A. de C.V. - February 18, 2016

ICU Medical de Mexico, S.A. de C.V. in Maneadero, Mexico, was inspected by the FDA from February 15-18, 2016. The inspection revealed significant deficiencies in process validation, particularly for solvent bonding, and a failure to adequately implement quality audit procedures. Additionally, the firm failed to properly document acceptance activities, specifically functional testing results for assembled units.