FDA 483 - Cavex Holland B.V. - March 05, 2020

An FDA inspection of Cavex Holland B.V., a manufacturer in Haarlem, Netherlands, identified three significant quality system deficiencies. The firm's MDR procedure lacked a standardized review process for adverse event reporting, and two complaints meeting reporting criteria were not submitted. Additionally, management review procedures were not adequately established, failing to report supplier performance, and procedures for ensuring purchased products and services conform to requirements were deficient, as evidenced by a lack of documentation for calibration service provider evaluations.