FDA 483 - Bio-Mechanical Composites, Inc. - August 09, 2019

An FDA inspection of Bio-Mechanical Composites, Inc. in Des Moines, IA, revealed significant deficiencies in their quality system. The firm failed to establish procedures for corrective and preventive actions (CAPA), medical device reporting (MDR), and the receiving, reviewing, and evaluating of complaints. These fundamental omissions indicate a lack of a robust quality management system for medical device manufacturing.