Devices

8 Observations in Zimmer Biomet FDA-483

FDA has released the FDA-483 issued following a 10/2-10/16/17 inspection at Zimmer Biomet’s manufacturing facility in Warsaw, IN. Specific observations were:

failing to adequately establish procedures for corrective and preventive action;
failing to adequately establish procedures to control product that does not conform to specified requirements;
failing to design and construct device packaging and/or shipping containers to protect the device from alteration or damage during processing, storage, handling, and distribution;
failing to adequately establish procedures monitoring and control of process parameters for a validated process;
failing to adequately validate software used as part of the quality system for its intended use according to an established protocol;
failing to adequately establish procedures to ensure equipment is routinely calibrated;
failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established; and
failing to implement written Medical Device Reporting procedures.

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