Drugs

FDA Finds Repeat CGMP Violations at B. Braun

A 4/18-5/11/16 FDA inspection at the B. Braun Medical facility in Irvine, CA, found repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/12 Warning Letter from the agency’s Los Angeles District Office. Specific violations cited in the letter were:

failing to establish and follow adequate written responsibilities and procedures applicable to the quality control unit; and
failing to routinely 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.

The letter says that the same or similar violations were found during FDA inspections in 2013, 2014, and 2015, and the violations were discussed at an 11/3/15 regulatory meeting with the company at FDA headquarters. “You proposed specific remediation for these violations in your responses,” the letter says. “Given the recurring nature of the violations, it is clear that your corrective and preventive actions are not robust and sustainable. Remediation efforts have not been adequately implemented. 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 says it strongly recommends that Braun engage a consultant to assist it in meeting CGMP requirements. The company was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome