Devices

QS Violations at BD Manufacturing Facility

A 5/16-8/1 FDA inspection at the Becton Dickinson manufacturing facility at Franklin, WI, found Quality System Regulation violations in the manufacture of a pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe. A 9/14 Warning Letter says specific violations were:

failing to adequately establish procedures to control environmental conditions;
failing to adequately establish procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality;
failing to adequately establish and maintain procedures to identify valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
failing to adequately validate a process whose results cannot be fully verified by subsequent inspection based on established procedure; and
failing to monitor production processes to ensure that a device conforms to its specifications.

The company was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each action, 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