Devices

FDA Issues Zimmer Biomet GMP Warning Letter

FDA has sent Zimmer Biomet a Warning Letter related to GMP deficiencies observed during a Quality System inspection in January at the company’s Montreal, Canada manufacturing facility. The company says the facility is the principal location of its wholly-owned subsidiary, ORTHOsoft, Inc. At the conclusion of the inspection, the agency issued a Form 483 with a list of observations, and the Warning Letter relates to these, the company says.

The Warning Letter does not restrict production or shipment of products from the Montreal facility or require the withdrawal of any product from the marketplace, Zimmer says, adding that it does not restrict its ability to seek 510(k) product clearance. However, the letter does say that, until the violations have been corrected, premarket approval applications for Class 3 devices to which the Quality System regulation deviations are reasonably related will not be approved. Zimmer says it presently has no such applications pending at the agency.

Since the inspection, Zimmer says it has provided detailed responses to FDA on its corrective actions and will continue to work expeditiously to address the issues identified. Zimmer believes that FDA’s concerns can be resolved without a material impact to the company’s financial results.

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