Drugs

FDA Warns Glaxo UK Active Pharmaceutical Ingredient Facility

FDA has cited a GlaxoSmithKline active pharmaceutical ingredient manufacturing facility in the UK after an inspection a year ago raised cross-contamination concerns. A just-released 6/30 Warning Letter says GSK failed to have appropriate procedures in place to prevent cross-contamination from a dedicated penicillin manufacturing area to non-dedicated areas. “We documented findings of penicillin in non-penicillin manufacturing areas approximately 69 times in 2012, 72 times in 2013, 30 times in 2014, and 16 times through July 7, 2015,” the letter says. “Your facility and controls to prevent contamination of non-penicillin drugs with penicillin are wholly inadequate. It notes that an internal product quality risk assessment after the inspection resulted in a recall involving various lots of Bactroban (mupirocin calcium) products “because of potential contamination with penicillin and foreign substances such as glass, paint fragments, and fibers.”

FDA also took issue with GSK’s method for detecting penicillin in non-penicillin drugs because it was not validated to detect the different types of penicillin manufactured at its facility. “In addition, you could not locate the raw data for the method validation,” the agency says. “Your firm has changed the method since the original validation.”

Additionally, the letter cites GSK’s investigations into microbial contamination in certain water systems. “Your investigations failed to adequately establish root causes,” it says. “In 16 of the 25 investigations, you concluded that the root cause was sampling error but had no supporting evidence. You did not determine a root cause in the remaining nine investigations.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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