Devices

QS Issues Found at Terumo Medical

A 10/19-10/23/15 FDA inspection at the Terumo Medical Corp. facility in Elkton, MD, found Quality System Regulation violations in the firm’s manufacturing of destination guiding sheaths for renal, carotid, and peripheral use. A 3/17 Warning Letter from the agency’s Baltimore District Office says that violations included:
failing to establish and maintain procedures to control nonconforming product; failing to establish and maintain procedures that define the responsibility for review and the authority for disposition of nonconforming product; failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications; failing to establish and maintain procedures for verifying the device design; failing to establish and maintain procedures for validating the device design; failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures; and failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

The letter says the firm’s responses were inadequate or their adequacy could not be determined. Terumo was told to take prompt action to correct the violations and to respond with a list of specific steps taken, 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’

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