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The company was cited for cGMP violations at its Irvine, California facility.
On May 17, 2017 FDA issued a warning letter to B. Braun Medical Inc. at 2525 McGaw Avenue, Irvine, CA based on an inspection conducted from April 18 to May 11, 2016. The warning letter cited several cGMP violations for finished pharmaceuticals.
According to the letter, the company failed to establish written responsibilities and procedures. “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,” the letter states.
The agency also noted that B. Braun had multiple field alert reports open without resolution. The company also failed to address issues related to leaking Titan XL bags. “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,” FDA wrote.
The company also “failed to calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment including computers, used in the manufacture, processing, packing, and holding of a drug product.” According to the letter, B. Braun failed to qualify its Pinhole Leak Detector Machine, which the company used during inspection of finished drug products.
According to FDA, the company was cited for similar violations in 2013, 2014, and 2015. “These repeated violations demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and ultimately, products conform to FDA requirements,” FDA said in the letter.