Devices

QS Violations Cited in TriMed Inspection

A 3/7-3/18 FDA inspection at TriMed, Inc., Santa Clarita, CA, found Quality System Regulation violations in the firm’s manufacturing of implantable bone fixation systems and the instruments and drills used to implant the products, according to a just-released Warning Letter from FDA’s Los Angeles District Office. Specific violations noted on an FDA-483 included:

failing to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, and packaging to meet any of its specifications where necessary;
failing to conduct a complete risk analysis;
failing to adequately establish procedures for corrective and preventive action;
failing to adequately establish procedures to control product that does not conform to specified requirements;
failing to adequately establish procedures for device history records;
failing to submit a report to FDA no later than 30 days after receiving or otherwise becoming aware of information, from any source, that reasonably suggests that a device the company markets may have caused or contributed to a death or serious injury;
failing to submit a report to FDA no later than 30 days after receiving or otherwise becoming aware of information from any source reasonably suggesting that a device the firm manufactures has malfunctioned and that the device or a similar device that the company markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
failing to implement Medical Device Reporting procedures; and
failing to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Federal Food, Drug, and Cosmetic Act by the device that may present a risk to health.

The company’s responses to the violations were not adequate, the letter says. TriMed 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