Devices

QS Violations at Mandelay Kft

A 10/14-10/17/19 FDA inspection at Mandelay Kft, Tokol, Pest, Hungary, found Quality System Regulation violations in the firm’s manufacturing of the Scientific Consciousness Interface Operation system and the Quantum University Energetic System Technology 9 devices. A just-released 2/3 Warning Letter says specific violations were:

failing to establish and maintain adequate procedures to control device design to ensure that specified design requirements are met;
failing to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications; and
failing to establish and maintain procedures to control labeling activities.

The letter says the firm’s responses did not address three of the inspection observations and did not adequately address the fourth. Mandelay was told to respond with a list of specific steps it has taken to correct the violations and prevent them from recurring, with documentation of each corrective action, which must address systemic problems, and a schedule for completion of the corrective actions.

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