Biologics

Lonza Cited Over Manufacturing, Quality Control at Swiss Plant

FDA cited multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, following an inspection in late 2025, according to a just-posted agency inspection report. The findings, detailed in a highly redacted Form 483 issued to the company’s Visp site, identify deficiencies in process controls, testing procedures, and equipment maintenance at the biologics manufacturing plant.

Among the observations, FDA investigators said the company applied inconsistent shelf-life specifications to drug substance batches compared with approved or documented standards.

Inspectors also flagged concerns with an integrity testing procedure used in manufacturing, noting it did not follow vendor recommendations and contained discrepancies between standard operating procedures and execution instructions. These inconsistencies included differences in test setup, timing parameters, and acceptance criteria — raising questions about the reliability of test results.

FDA also cited inadequate control of process parameters during manufacturing, including deviations in critical process parameters during both qualification and commercial batches.

Some batches showed out-of-specification or borderline analytical results at release, including assay values falling below established limits. Investigators noted excursions beyond validated operating ranges during key production steps, suggesting gaps in process control and monitoring.

Additionally, the agency raised issues with equipment lifecycle management, stating that certain critical components used in manufacturing were not adequately tracked, maintained, or replaced. In one instance, inspectors observed potential contamination or foreign material impacting an integrity test during the inspection, with unclear implications for product quality. Other equipment used in sealing drug substance containers lacked unique identification numbers and was not subject to routine calibration.

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