FDA Warns B. Braun Medical’s California Plant for Repeat Violations
The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015.
FDA found in its latest inspection from 18 April to 11 May 2016 that B. Braun’s "quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse trends."
One of the major issues cited by FDA is that B. Braun has received customer complaints related to visible particulate matter and leaking IV bags but has not resolved them in some cases.
"While reviewing your field alerts, we determined the status of investigations relating to 76 field alert reports (FAR) that you filed for parenteral drugs produced on your partial additive bag (PAB), Excel, and Titan XL lines. Of these FAR, 44 were related to customer complaints regarding visible particulate matter and leaking intravenous (IV) bags," FDA said. "While you opened investigations into these significant complaints, some investigations have been open for extended periods without resolution."
B. Braun told Focus in a statement: "This warning letter was in response to observations identified by the FDA during inspections at B. Braun's Irvine facility in April/May 2016 and earlier. B. Braun has already implemented numerous actions to not only address the identified issues but also improve the underlying quality system. B. Braun intends to work collaboratively with the FDA to assure that outstanding issues are addressed in a timely manner."