FDA 483 - B. Braun Medical Inc - June 29, 2018

B. Braun Medical Inc. in Irvine, CA, a sterile drug manufacturer, received an FDA Form 483 citing significant deficiencies in laboratory controls and data integrity. Observations included incomplete laboratory records, manipulation of test data, inadequate computer system controls, and a failure to establish proper test method specificity and impurity specifications. These findings indicate serious concerns regarding the reliability of product quality testing and overall data management practices.