Drugs

Multiple Violations at China’s Xiamen Kang

An 8/12-8/16/2025 FDA inspection at the Xiamen Kang Zhongyuan Biotechnology Co. drug manufacturing facility in Fujian Sheng, China, found its products are adulterated due to being prepared, packed, or held under insanitary conditions. A just-released 3/23 Warning Letter says the company did not have adequate controls in place to maintain a suitable production environment and to prevent contamination of drug products manufactured at the facility.

The letter also says the company made misleading or deceptive statements during the inspection and may have delayed the investigators’ access to accurate and truthful information.

Following a 3/4 teleconference between FDA and the company, the letter says, the company recalled specific lots of mentholated cough drops currently in distribution in the U.S. FDA placed all of the firm’s products on a 3/20 Import Alert.

Xiamen Kang was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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