Devices

7 QS Issues at 3 Integra Facilities

FDA inspections at three Integra Lifesciences medical device facilities (Mansfield, MA, 3/12/2024-6/5/2024; Plainsboro, NJ, 4/9/2024-8/22/2024; and Princeton, NJ, 3/12/2024-8/22/2024) found Quality System Regulation violations in the firm’s manufacturing of neurological and neurosurgical medical devices. A just-released 12/19/2024 Warning Letter says specific violations were:

failure to establish and maintain procedures to control product that does not conform to specified requirements, addressing the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and determining the need for an investigation and notification of the person or persons responsible for the nonconformance;
failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities;
failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
failure to establish and maintain procedures for corrective and preventive action;
failure to review and evaluate process changes and deviations and perform revalidation when changes or process observations occur;
failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to adversely affect product quality; and
failure to validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test.

The letter says FDA could not determine the adequacy of the firm’s responses to the inspection observations. Integra was told to take prompt action to address the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for their 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