Devices

QS Violations at Unetixs Vascular

A 3/6-3/29 FDA inspection at Unetixs Vascular, North Kingstown, RI, found violations of the Quality System Regulation in the firm’s manufacturing of vascular diagnostic ultrasound systems such as the MultiLab Series 2. A 4/25 Warning Letter says that significant violations included:

failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications;
failing to establish and maintain procedures for implementing corrective and preventive actions;
failing to document corrective and preventive action activities;
failing to establish and maintain procedures for changes to a specification, method, process, or procedure; and
failing to establish and maintain procedures for acceptance activities including inspections, tests, or other verification activities.

The company was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken, with documentation of each step and a timetable for completion.

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