Devices

Multiple Violations in Qiagen U.S. Facility

A 1/19-2/5 FDA inspection at the Germantown, MD, manufacturing facility operated by Germany’s Qiagen found multiple violations in the firm’s manufacturing of the QuantiFERON-TB Gold test device, according to a 5/16 Warning Letter. Violations listed on an FDA-483 included:

procedures for corrective and preventive actions were not adequately established to ensure that the actions are effective;
requirements that must be met by suppliers and contractors were not adequately established;
procedures for design change were not adequately established;
procedures for design output were not adequately established;
complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary;
sampling plans are not written and based on valid statistical rationale;
a report was not submitted to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device that the firm markets had malfunctioned and that the device or a similar one would be likely to cause or contribute to a death or serious injury;
failing to adequately develop, maintain, and implement written medical device reporting procedures; and
failing to submit a written report to FDA of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device.

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, 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