Drugs

FDA Cites Emcure Pharmaceuticals' India Pant Over GMP Issues

FDA has cited Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection conducted in May, according to a just-posted Form 483. The nine-page inspection report contains seven observations covering equipment qualification, complaint investigations, laboratory controls, aseptic processing, contamination controls and computerized systems.

Among the findings, FDA investigators said the company failed to adequately qualify manufacturing equipment used to produce sterile injectable drug products. The agency said Emcure did not perform protocol-driven performance qualification studies for certain manufacturing equipment and failed to complete required requalification studies after introducing a new vial configuration. Investigators also noted the company did not evaluate the equipment under worst-case operating conditions despite having received about 225 complaints involving displaced stoppers on one of its injectable products.

FDA also criticized the company's handling of product complaints, saying investigations were not conducted when complaints identified a product but lacked a batch number. According to the inspection report, Emcure's own procedures require broader evaluations of quality-related information — including deviation histories, stability data, retention samples and out-of-specification investigations — but investigators found several complaints had been closed without a full root-cause investigation or corrective and preventive actions.

Additional observations cited inadequate laboratory testing of certain incoming raw materials before use in manufacturing and weaknesses in computerized system controls. FDA said the firm's audit trail review procedure allowed quality assurance personnel to rely on paper or PDF copies rather than reviewing electronic audit trails directly, and that chromatographic software settings allowed analysts to view analytical results before finalizing chromatograms, creating a potential data integrity concern.

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