483
MEDTRONIC ATS MEDICAL, INC.MEDTRONIC ATS MEDICAL, INC. – FDA 483, Jan 15, 2026
Record Details
An FDA inspection of MEDTRONIC ATS MEDICAL, INC. in Plymouth, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA) and for controlling nonconforming products. These issues indicate a lack of robust quality management practices.
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ID · c58f42a6-8c02-4a7b-b0e3-1a2d7fc70205
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