Devices

QS, MDR Violations at Fresenius Kabi Facility

An 8/15-9/7/2023 FDA inspection at the Fresenius Kabi USA facility in North Andover, MA, found Quality System and Medical Device Reporting violations in the facility’s work as a specification developer and manufacturer of the Ivenix Infusion System. A just-released 1/4 Warning Letter says the specific Quality System violations were:

failing to establish procedures for corrective and preventive action;
failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
failing to establish procedures for validating the device design and failing to include software validation and risk analysis, where appropriate; and
failing to establish procedures for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation.

The Medical Device Reporting (MDR) violations were:

failing to report to FDA required information no later than 30 days after receiving or otherwise becoming aware of information, from any source, reasonably suggesting that a marketed device has malfunctioned and the device or a similar marketed device would be likely to cause or contribute to a death or serious injury; and
failing to adequately develop, maintain, and implement written MDR procedures.

The letter also says the firm’s Ivenix system is misbranded in that Fresenius failed or refused to furnish material or information about the device involving reports of corrections or removals.

FDA says the company’s responses to the inspection observations were inadequate or could not be evaluated. Fresenius Kabi was told to promptly 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 the corrective actions and a schedule for completing them. FDA also proposes a 1/19 virtual regulatory meeting to discuss its concerns and have the firm comment on the status of its proposed 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