Devices

LC Medical Concepts Warned on Wound Kit Manufacturing

FDA has sent LC Medical Concepts a 1/31-dated Warning Letter after a 10/2018 inspection of the firm’s Rochester, NY, medical device operations found GMP concerns with the manufacturing of negative pressure wound therapy kits. The agency cited the company for failing to adequately validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test. For example, the company moved its manufacturing operations, but it did not assess the bioburden and particulate loads at the new site. “No assessment was done of the effects these changes may have on the sterilization process,” the letter said.

The letter also cited LC Medical for failing to ensure equipment used for manufacturing, inspection and testing is routinely calibrated. For example, the inspection found that equipment used to manufacture and test products was not calibrated according to a calibration schedule and that no calibration schedule is in place, it said.

Additionally, FDA said the company failed to verify or validate corrective and preventive actions (CAPA) to ensure the actions were effective and did not adversely affect finished devices. Specifically, FDA said two out of three CAPAs reviewed did not include verification or validation of CAPA effectiveness. “Both CAPAs were closed the same day as initiation, with no effectiveness check,” the letter said.

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