B. Braun Medical Inc FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

During the inspection, we observed that your quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse trends. Your written procedures (e.g., Corrective/Preventive Action Program Quality Procedure; Discrepancy Management System (DSMS) Quality Procedure) require that you take appropriate corrective action and preventive action (CAPA) to address root causes in a timely manner. However, in many instances, implementation of corrective actions was significantly delayed or the actions implemented were ineffective.

Container-closure integrity is imperative to ensure sterility of parenteral drugs, and manufacturing operations should be designed to prevent visible particle contamination.

During our previous inspections in February 2014 and March 2015, we observed that your quality unit failed to ensure that adequate CAPA were implemented to control your processes and prevent the release of defective product.

Potential Health Risks

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

A further investigation, documented in your report dated December 18, 2015, was conducted to simulate distribution and handling of your product. This investigation also identified lost integrity during shipment and distribution as the likely root cause of leaking units. In addition, you determined through your investigations that your initial shipping studies had not adequately simulated the distribution of your drug products from the manufacturing site to the end user.However, our May 2016 inspection found that, approximately 28 months after the investigation was opened, you had not implemented corrective actions despite identifying an adverse trend and many FARs submitted to FDA regarding Titan IV bag leaks.  Since our inspection, your firm has submitted several additional FAR regarding

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, atdrugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

Regulatory Context

Mr. Sergio CasasActing General ManagerVice President and General ManagerB. Braun Medical, Inc.2525 McGaw AvenueIrvine, CA 92614

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, B. Braun Medical, Inc., at 2525 McGaw Avenue, Irvine, from April 18 to May 11, 2016.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).