FDA 483 - Covidien - April 28, 2022

An FDA inspection of Covidien Davis & Geck Caribe LCD & Medtronic Dominicana (Manufactura) S.A. in San Isidro, Dominican Republic, revealed significant quality system deficiencies. The firm failed to adequately validate the mixing process for radiopaque markers used in medical devices and did not establish or fully implement adequate procedures for acceptance activities, including incoming material verification and in-process acceptance. These issues indicate a lack of control over critical manufacturing processes and material quality.