Devices

Innovative Sterilization QS Issues

An 8/4-8/13/15 and 10/6-11/4/15 FDA inspection at Innovative Sterilization Technologies, Dayton, OH, found Quality System Regulation violations in the firm’s work as the specification developer of the One Tray sealed sterilization container. A 3/2 Warning Letter from the agency’s Cincinnati District Office says that specific violations noted on an FDA-483 included:
failing to establish and maintain procedures for implementing corrective and preventive actions; failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met; failing to establish and maintain adequate procedures for receiving, reviewing, evaluating, and investigating complaints by a formally designated unit; failing to establish and maintain procedures for changes to a specification, process, or procedures; and failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

The letter also says that the firm failed or refused to furnish material or information about the device that is required under the reports of correction and removals regulation.

Innovative 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