FDA 483 - BALT USA, LLC - March 12, 2020

An FDA inspection of BARD USA, LLC, a medical device manufacturer in Irvine, CA, revealed a significant issue with their quality system. The firm failed to adequately establish procedures for controlling nonconforming products, specifically regarding the lack of root cause investigations for a substantial number of nonconformance reports. This indicates a moderate severity issue related to quality control and adherence to internal procedures.