Devices

2 QSR Violations at Qinjiang Kingphar Medical

A 6/30-7/3 FDA inspection at Qinjiang Kingphar Medical Material Co. in Qinjiang, China, identified two Quality System Regulation violations in the firm’s manufacturing of surgical masks, wound dressings, sterilization wraps, and surgical drapes. A 10/3 Warning Letter says the specific violations were:

failure to establish and maintain procedures to prevent contamination of equipment or products by substances that could reasonably be expected to have an adverse effect on product quality (repeat observation); and
failure to establish and maintain procedures to adequately control environmental conditions which could reasonably be expected to have an adverse effect on product quality, and to periodically inspect the environmental control system to verify that the system, including necessary equipment, is adequate and functioning properly.

Qinjiang was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation of each action and a schedule 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