Devices

QS, MDR Violations at Luminex Corp.

A 2/10-2/14 FDA inspection at Luminex Corp., Austin, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s work as a manufacturer of microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or life science research use, including software and hardware, reagents, and cassettes. A 6/26 Warning Letter says specific Quality System violations relating to the Verigene Processor SP System were:

failing to validate a process when changes or process deviations occurred;
failing to adequately establish procedures for corrective and preventive action;
failing to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements;
failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements; and
failing to establish procedures for monitoring and control of process parameters for a validated process.

The letter says Luminex also failed to submit a written report 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 that may present a risk to health.

The company was told to take prompt actions to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence with documentation of each step and a timetable for completing the corrections.

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