FDA 483 - SMITHS MEDICAL ASD, INC. - June 09, 2023

An FDA inspection of Smiths Medical ASD, Inc. in Oakdale, MN, revealed significant deficiencies in process control procedures and the handling of nonconforming products. Operators were found to be deviating from established testing protocols, and the firm's investigation into nonconformances failed to adequately identify all potentially affected products, some of which were distributed. These issues indicate a breakdown in quality system adherence and oversight.