Devices

Abbott Diabetes Care QS Violations

A 10/14-10/23/2025 FDA inspection at the Abbott Diabetes Care facility in Alameda, CA, found Quality System Regulation violations in the firm’s manufacturing of flash and continuous glucose monitoring systems. A 1/23 Warning Letter says the specific violations were:

failure to adequately establish and maintain procedures to ensure that the device is correctly translated into production specifications;
failure to adequately establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
failure to adequately establish and maintain procedures, where appropriate, for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics; and
failure to adequately establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions.

The letter says Abbott’s responses to the inspection observations were inadequate.

FDA told the company to take prompt action to address the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of 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

Read more

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