Devices

QS Violations at Noah Medical Corporation

A 10/28-11/26/2024 FDA inspection at Noah Medical Corporation in San Jose, CA, found Quality System Regulation violations in the firm’s manufacturing of the Galaxy System bronchoscopes and accessories. A 4/9 Warning Letter says the specific violations were:

failure to establish and maintain procedures for corrective and preventive action;
failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to establish and maintain procedures for design control;
failure to establish and maintain procedures to control product that does not conform to specified requirements;
failure to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework to ensure that the product meets the current approved specifications; and
failure to submit a Medical Device Report no later than 30 days after receiving or otherwise becoming aware of information reasonably suggesting that a device the firm markets may have caused or contributed to a death or serious injury.

FDA says the adequacy of the firm’s responses to the inspection observations could not be determined. It told Noah to take prompt action to address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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