Devices

QS, MDR Issues at Taiwan’s Visgeneer

A 2/24-2/27 FDA inspection at Visgeneer, Inc., in Hsinchu City, Taiwan, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of a glucose monitoring system and a blood uric acid monitoring system. A just-released 6/13 Warning Letter says the specific violations were:

failure to adequately establish and maintain procedures for validating device design;
failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, including quality requirements, that must be met by suppliers, contractors, and consultants; and
failure to submit any report required within 10 working days of initiating a correction or removal.

The letter says the firm’s responses to the inspection observations were inadequate or their adequacy could not be determined. FDA says it is taking steps to refuse entry of the company’s devices in the U.S. through detention without physical examination until the violations are addressed.

Visgeneer was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions 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