Devices

QS Violations at Spectranetics

A 11/30-15-1/21/16 FDA inspection at Spectranetics Corp., Colorado Springs, CO, found Quality System Regulation and other violations in the firm’s manufacturing of lead management disposable catheter lines, including laser sheath device products, specifically the GlideLight and SLS II sheaths. A 5/23 Warning Letter from the agency’s Denver District Office says the two specific sheath devices reviewed contain a Class 4 laser. Specific violations cited in the letter include:

failing to validate a process whose results cannot be fully verified by inspection and test;
failing to adequately document risk analysis;
failing to adequately document corrective and preventive action procedures;
failing to perform quality re-audits;
failing to comply with the electronic product radiation controls certification requirement;
failing to submit accidental radiation occurrence reports; and
failing to submit a supplemental electronic product radiation control report on a new or modified model.

The letter says that the inspection observations “may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt action to correct the violations and to bring your products into compliance.”

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, 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