Devices

Unetixs Vascular QS Violations

A 9/17-10/29/19 FDA inspection at Unetixs Vascular, North Kingstown, RI, found Quality System Regulation violations in the firm’s manufacturing of vascular diagnostic ultrasound systems such as its MultiLab series of devices. A 2/4 Warning Letter says significant violations were:

failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
failing to establish and maintain procedures for acceptance activities that include inspections, tests, or other verification activities;
failing to establish and maintain procedures for implementing corrective and preventive actions;
failing to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications.

Unetixs was told to take prompt action to address the violations. The company was told to submit to FDA certification by an outside expert that the firm’s manufacturing and quality assurance systems had been audited relative to the requirements of the device Quality System regulation. It also was told to submit a list of specific steps it has taken to correct the violations and prevent their recurrence, with a timetable for completing the actions.

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