Devices

QS Violations at Xoran Technologies

A 6/25-7/11/2024 FDA inspection at Xoran Technologies in Ann Arbor, MI, identified Quality System Regulation violations in the firm’s manufacturing of computed tomography systems and supporting software. A just-released 12/9/2024 Warning Letter says the specific violations were:

failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failure to adequately establish and maintain procedures for validating the device design to include an adequate software validation;
failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner; and
failure to establish and maintain procedures for validating the device design to include an adequate risk analysis.

FDA says the firm’s responses to the inspection observations were inadequate or the adequacy could not be determined. In addition, the agency says some of the firm’s medical devices are adulterated because Xoran does not have an approved PMA or IDE in place for them. The devices are misbranded, the letter says, because Xoran did not notify FDA of its intent to introduce them into commercial distribution. FDA also says the company made changes to some of its products that could significantly affect their safety or effectiveness.

Xoran was told to act promptly to correct 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

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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