Drugs

FDA Cites Australian Drug Manufacturer for Quality System, Testing Deficiencies

FDA has cited Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of its Rocklea, Queensland facility, according to a just-posted five-page Form FDA 483 issued at the close of the inspection.

The inspection, conducted at the company's finished product manufacturing facility, identified six observations spanning quality oversight, laboratory controls, component testing, stability, and microbiological controls. FDA's first observation said the company had not established written procedures defining the responsibilities and authority of its quality control unit, leaving personnel unclear about their quality-related duties.

Among the most significant findings, FDA said the firm's quality unit lacked the authority to approve or reject drug products. Investigators found manufacturing operations proceeded without qualified quality assurance personnel overseeing critical production steps, with production employees performing QA functions. The agency also cited examples in which product lots were released without final QA approval, products were distributed while an out-of-specification investigation remained open, and multiple lots were released to the U.S. market before the contract laboratory had completed finished-product testing and issued certificates of analysis.

FDA also criticized the company's laboratory controls, stating that from June 2024 through May 2025 the firm released multiple product lots to the U.S. without performing required microbiological testing, despite formulations containing ingredients that increased microbiological risk. In a separate observation, investigators said the company relied solely on suppliers' certificates of analysis for certain raw materials without conducting required identity testing on each received lot.

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