Devices

Cardinal Health Monoject Inspection Violations

A 12/11-12/20/2023 FDA inspection at the Cardinal Health facility in Waukegan, IL, found violations in the firm’s work as an importer/own label distributor of two types of Monoject syringes. A 4/24 Warning Letter says the syringes included in convenience kits marketed by the company are adulterated because Cardinal does not have an approved PMA or IDE in place for them. The letter also says the devices are misbranded because Cardinal did not notify FDA of its intent to introduce them into commercial distribution.

The letter says the Quality System Regulation violation was a failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements.

Cardinal was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation for each action and 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