Devices

QS Issues in Criticare Inspection

A 3/21-5/10 FDA inspection at a Criticare Technologies medical device operation in Warwick, RI, found that the patient monitors it manufactures, including the nGenuity patient vital signs monitor, are adulterated due to violations of the Quality System regulation. A 7/12 Warning Letter says specific violations were:

failure to establish and maintain procedures for implementing corrective and preventive actions;
failure to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
failure to establish and maintain procedures to ensure that all received product conforms to specified requirements; and
failure to establish and maintain procedures to control product that does not conform to specified requirements, including procedures to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.

FDA says the first inspection observation is repeated from a previous inspection and that all of the firm’s responses to the observations are not adequate. Criticare was told to take prompt action to address the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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

Read more

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