Devices

Quality System Violations at Vilex

An 8/16-8/25/17 FDA inspection at Vilex in Tennessee, McMinnville, TN, found Quality System Regulation violations in the firm’s work as a specification developer and relabeler/repacker and conducting limited manufacturing operations for its Class 1 and 2 orthopedic implants and tools. A just-released 1/9 Warning Letter says violations listed on an FDA-483 were:

failing to establish design history files;
failing to adequately establish procedures for design validation;
failing to adequately establish procedures to ensure that all purchased or otherwise received product or services conform to specified requirements;
failing to adequately document results of the design risk analysis; and
failing to document rework and reevaluation activities in the device history record.

The agency acknowledges the firm’s commitment to correcting all the noted violations. Vilex was told to take prompt action to correct the violations addressed in the letter and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, along with 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’

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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

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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