FDA 483 - SMITHS MEDICAL ASD, INC. - April 11, 2018

An FDA inspection of SMITHS MEDICAL ASD, INC. in Oakdale, MN, revealed a lack of an established quality plan and inadequate control over contract suppliers. Specifically, the firm failed to ensure that critical components for their Medfusion infusion pumps met specifications, leading to out-of-specification parts contributing to field failures. This indicates significant deficiencies in their quality management system.