FDA warning letter slams B. Braun management for persistent failures at U.S. plant

FDA
An FDA warning letter had severe language for the executive management of a B. Braun Medical plant in California that failed to resolve issues with leaking bags of parenteral drugs.

The FDA has brought its regulatory hammer down on a B. Braun plant in California that makes parenteral drugs, saying management let problems go on for more than two years, even after the agency repeatedly told them the plant needed to get its act together.  

A warning letter issued three weeks ago and posted Tuesday by the agency pointed out that some of the problems, or similar issues, were cited by investigators during inspections in 2013, 2014, and 2015. The FDA laid everything out in an untitled letter in July 2014, then followed that up with a regulatory meeting with FDA staff in November 2015.

Despite all of that, the warning letter said, some of the issues had still not been addressed when investigators returned in April 2016 for their last inspection.

The FDA told the company the “repeated violations demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.” It said the Melsungen, Germany-based company should do a comprehensive assessment of its “global manufacturing operations” and suggested it get an outside consultant to help.

Among B. Braun’s failures, the FDA pointed to nearly four dozen unresolved customer complaints the company received for its Excel and Titan XL lines of flexible containers for irrigation and parenteral nutrition solutions for compounding. While the complaints went on for months, the company never fully resolved the underlying issues, the FDA said, including some of mold in bags.

The agency said B. Braun began receiving complaints of leaking bags containing 0.9% sodium chloride irrigation in October 2013, just a month after the plant had launched its Titan XL line. The plant's investigation, opened in January 2014, indicated the likely cause was failing port welds that were damaged during shipping. Tests to simulate shipping, which were not done until December 2016, pretty much confirmed that as the cause of the problem.

“However, our May 2016 inspection found that, approximately 28 months after the investigation was opened, you had not implemented corrective actions,” the FDA said.

Investigators found a similar pattern with complaints about mold in bags, the letter said, noting that during the 2016 inspection the plant had not “adequately implemented corrective actions to address repeated instances of leaking IV bags and visible particulate matter.”

This is the second regulatory action for B. Braun's supply chain this year. In January, the company ran afoul of regulators in Europe when an inspection of a warehouse in the Czech Republic found that it didn't "comply with the Good Distribution Practice requirements.” That prompted the EMA to suspend authorization for the warehouse and order the “immediate” transfer of the drugs to another approved facility.