FDA 483 - Nitinol Devices and Components Costa Rica, S.R.L. - February 06, 2020

An FDA inspection of Mitchel Devices and Components Costa Rica, S.R.L., a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient equipment inspection and maintenance, and untimely processing of customer complaints. These issues indicate systemic problems in maintaining a compliant quality management system.