Drugs

FDA Cites Sterile Compounding Lapses at Nubratori

FDA has cited Nubratori Inc., a California-based sterile drug outsourcing facility, for multiple manufacturing and contamination-control deficiencies following a December inspection of the company’s Torrance site, according to an agency inspection report. The Form FDA 483 said the company failed to establish adequate written procedures for cleaning and maintaining manufacturing equipment. Inspectors also faulted the company for selecting a non-sterile product as its designated “worst-case” compound without sufficient scientific justification and for continuing to rely on that designation even after introducing new sterile injectable products with potentially greater cross-contamination risks. In addition, FDA said Nubratori performed a cleaning verification activity in 2025 without first completing adequate cleaning validation studies, a step the agency said is required to demonstrate consistent cleaning effectiveness.

The inspection also identified deficiencies in production and process controls. FDA said Nubratori modified vial filling configurations for two sterile injectable products — Lidocidex I and Lidomar — without conducting appropriate process validation. Investigators noted that the company’s risk assessment did not adequately evaluate critical factors such as sterility assurance, filling dynamics, and aseptic manipulation techniques. The agency said that media fill studies alone were improperly used as a substitute for full process validation with actual drug products.

In a third major observation, FDA investigators said Nubratori lacked adequate written procedures to prevent microbiological contamination of sterile drugs. The agency cited deficiencies in airflow smoke studies and described practices observed during compounding that could disrupt unidirectional airflow in laminar airflow hoods. Inspectors reported seeing personnel prepare environmental monitoring plates inside critical aseptic areas, including opening packaging and labeling plates with non-sterile markers, actions the FDA said introduced unnecessary contamination risks.

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