Devices

QS Violations at Denterprise International

A 5/1-5/6 FDA inspection at Denterprise International, Ormond Beach, FL, found Quality System Regulation and other violations in the firm’s work as specification developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. A 10/9 Warning Letter says specific violations, that were all repeat deficiencies, were:

although not appearing on the FDA-483, failing to establish procedures for design control;
failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirement;
failing to include information in complaint records;
failing to adequately establish procedures for quality audits;
failing to adequately establish procedures for acceptance activities; and
failing to establish and maintain procedures for device history records.

The inspection also identified a radiological health significant deviation for failing to report immediately to the CDRH director an accidental radiation occurrence reported to or otherwise known by the company involving a product introduced or intended to be introduced into commerce by the company.

Denterprise was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence with documentation of each step and a timetable for implementation.

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