Devices

FDA Finds Violations in 2 Medtronic Inspections

FDA inspections at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico, and Medtronic’s Cardiac Rhythm and Health Failure business, Mounds View, MN, found violations of FDA regulations, according to Warning Letters sent to each facility. The 8/23 Puerto Rico Operations Warning Letter says investigators found Quality System regulation violations in the firm’s manufacturing of implantable pacemakers, implantable cardioverter defibrillators, cardiac resynchronization devices, and other related products. Specific violations cited were:

failing to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures; and
failing to document redacted activities in the device history record.

The letter says investigators cited observations on the FDA-483 in the areas of corrective and preventive action; acceptance activities; statistical techniques; and inspection, measuring, and test equipment. It says the firm’s responses appear to adequately address those observations.

Medtronic was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and an explanation of how the firm plans to prevent those or similar violations from occurring again, along with documentation of corrective actions, and a timetable for completion.

The 7/30 Warning Letter for the Cardiac Rhythm business identifies Quality System regulation violations in the manufacturing of implantable pacemakers, implantable cardioverter defibrillators, cardiac resynchronization devices, cardiac ablation catheter systems, cardiac monitoring and diagnostic devices, and other related products. Specific violations were:

failing to establish adequate procedures for design transfer; and
failing to establish adequate procedures for changes to a production process.

The letter says investigators noted on an FDA-483 that the firm’s actions on a specific corrective and preventive action procedure were not commensurate with risk or conducted as required by the firm’s procedure. The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of the corrective actions, 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