Drugs

Lupin Hit with Another FDA-483

FDA has issued a five-item Form FDA-483 after conducting a pre-approval inspection of Lupin’s Nagpur, India Unit-2 injectable manufacturing facility 10-17-29. “We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S.,” the company says.

Lupin appear to have seen increased attention by FDA this year. Last week, the agency released the Form FDA-483 issued following a 10/3-10/14 inspection at the Lupin drug substance and drug product manufacturing facility in Pune, Maharashtra, India. Specific observations were inadequate aseptic monitoring for the fill line and its filling and cleaning machine, failing to make an adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in an area classified by the company as Grade A, and aseptic processing areas are deficient regarding the system for monitoring environmental conditions, among others.

And earlier this month, FDA posted a Warning Letter that resulted from a 3/22-4/4 inspection at Lupin’s manufacturing facility in Palghar, Maharashtra, India, which cited significant GMP deviations for active pharmaceutical ingredients made at the plant. The agency said that Lupin’s response to the Form FDA-483 was inadequate because it did not provide sufficient detail or evidence of corrective actions to bring the company’s operation into compliance with GMPs. The letter also acknowledged Lupin’s commitment to suspend the production of drugs for the U.S. market and says if the company plans to resume manufacturing drugs for the U.S. market it should notify FDA before doing so.

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