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Drugmaker Warned Over Long-Term Quality Problems

June 6, 2017

The FDA sent a warning to a drug manufacturing facility in Irvine, Calif., for failure to resolve quality issues dating back to 2013.

According to the agency’s warning letter, B. Braun Medical’s Irvine plant had long-term quality issues and had failed to comply with current good manufacturing practices, resulting in consumer complaints and concerns about adulterated drug products.

An FDA inspection in spring 2016 revealed that the company had 76 field alert reports, including 44 related to customer complaints regarding visible particulate matter and leaking intravenous bags, but the corrective actions were significantly delayed or ineffective, according to the letter.

Customer complaints about bag leaks began in October 2013, but after having an open investigation for 28 months, B. Braun had not implemented corrective actions, the agency said.

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