FDA cites Braun Medical for repeat GMP violations
- The Food and Drug Administration is fed up with B. Braun Medical, issuing a warning letter to the company's Irving, CA, facility earlier this month that criticized the medical product manufacturer for failing to correct repeat violations.
- More than 40 field alert reports flagged visible particulate matter or leaking intravenous bags for parenteral drugs that were produced on Braun's partial additive bags (PABs), Excel and Titan XL lines. Although Braun opened investigations to find the cause of the leaking units, inquiries were left unfinished and corrective actions were never taken.
- What's more, this isn't the first time Braun has run afoul of the FDA's GMP standards. In the warning letter, the regulator noted that inspections in 2013, 2014 and 2015 had all cited either the same or similar violations.
Much of the attention on the FDA's regulation of manufacturing facilities has centered on its stepped-up oversight of facilities in India and China through the Center for Drug Evaluation and Research.
But the agency's field offices in the U.S. are also busy policing manufacturers.
B. Braun Medical specializes in infusion therapy and pain management, but also manufactures a range of medical products for the biomedical industry.
Braun launched its Titan XL bag line containing sodium chloride irrigation in September 2013. By October, Braun had begun to receive complaints of leaking units and opened an investigation in January 2014. A subsequent report blamed failing welds as the root cause, and further examination of the issue identified lost integrity during shipping and distribution as a problem.
But 28 months after opening an investigation, Braun had not taken any corrective actions despite more field action reports citing leaking Titan intravenous bags, the FDA said.
Similar problems cropped up with Braun's PABs. Although Braun upped test pressure to improve detection of leaks, the quality control unit didn't make sure the test was actually adequate to detect leaks in PAB production lines.
Similar problems were detailed in a 2014 untitled letter and discussed with Braun at a 2015 meeting at the FDA's headquarters.
"These repeated violations demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs," the FDA wrote in its warning. "You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and ultimately, products conform to FDA requirements."
In addittion, the FDA recommended Braun retain a cGMP consultant.
- FDA Warning letter
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