Devices

QS Violations Seen in Leventon Inspection

A 3/19-3/22 FDA inspection at Leventon S.A.U., Barcelona, Spain, found Quality System Regulation violations in the firm’s manufacturing of the Dosi Flow elastomeric infusion pump and Dosi Flow administrative set. A 9/5 Warning Letter says that specific violations listed on an FDA-483 were:

failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedure;
failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before implementation;
failing to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met; and
failing to submit a report to FDA no later than 30 calendar days after receiving or otherwise becoming aware of information, from any source, that reasonably suggested that a device the firm markets had malfunctioned and that the device or a similar device the company markets would be likely to cause or contribute to a death or serious injury.

“The specific violations noted in this letter and in the inspectional observations, FDA-483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems,” FDA says. “Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.”

The company 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 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