Devices

QS Violations at Sweden’s Sonesta Medical

A 6/5-6/7/2023 FDA inspection at Sonesta Medical AB in Solna, Sweden, found Quality System Regulation violations in the firm’s manufacturing of a radiographic table and two cystometric tables. A just-released 9/22/2023 Warning Letter says the specific violations were failing to establish and maintain procedures:

to ensure that all purchased or otherwise received products and services conform to specific requirements;
for receiving, reviewing, and evaluating complaints by a formally designated unit;
to ensure that the design requirements relating to a device are appropriate and address the intended device use;
for validating the device design under defined operating conditions on initial production units, lots, or batches, or their equivalents;
for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation;
to control all documents.

The letter says the firm failed to respond to two of the inspection observations and its responses to the remaining four were inadequate.

Sonesta was told to respond with a list of specific steps it has taken to respond to 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