Devices

Cook Medical Gets Warning Letter Close-out

Cook Medical has received an FDA close-out letter resolving a 2014 Warning Letter for processes related to the company’s quality system at its manufacturing facility in Bloomington, IN. The Warning Letter from the Detroit District Office said that violations noted in the inspection included:

failing to validate, with a high degree of assurance, and approve according to established procedures a manufacturing process that cannot be fully verified by subsequent inspection and testing to ensure the process will continue to meet specifications;
failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure the specified requirements continue to be met;
failing to establish and maintain procedures for implementing corrective and preventive action;
failing to establish and maintain procedures for accepting incoming products to ensure conformance with specified requirements;
failing to establish and maintain procedures to control product that does not conform to specified requirements;
failing to establish and maintain written sampling plans based on valid statistical rationale that are adequate for their intended use; and
failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

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