Drugs

Nephron Pharma Hit Again with FDA-483

Nephron Pharmaceutical appears to be under a continuing microscope at FDA after an inspection earlier this year resulted in a just-posted 15-item Form FDA-483 that cites numerous GMP deficiencies. The inspection came on the heels of a 10/2022 Warning Letter that cited several GMP issues and found that the firm failed to submit an NDA Field Alert Report within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product (see earlier story).

The agency recommended in the Warning Letter that Nephron retain a qualified consultant to perform a comprehensive audit of Nephron’s entire operation for CGMP compliance, assist the firm in meeting CGMP requirements, and evaluate the completion and efficacy of all identified corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

The latest inspection, which concluded 2/10, found that the company’s responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. FDA investigators also found that aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Additionally, the inspection found that procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

A Nephron statement about the latest inspection provided to the Columbia, SC Post and Courier says the company has made strides to correct issues that inspectors raised. “In the months since FDA last visited Nephron, we have worked overtime: engaging expert consultants, hiring new talent and addressing any questions inspectors had as a part of the continuous improvement and innovation for which Nephron has come to be known,” CEO Lou Kennedy said.

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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