Devices

QS Violations Found in Grams Medical Inspection

A 9/14-25/15 FDA inspection at Grams Medical Products, Costa Mesa, CA, found Quality System Regulation violations in the firm’s manufacturing of the Grams Aspirator S-300. A just-released 3/17 Warning Letter from the agency’s Los Angeles District Office says that violations listed on an FDA-483 included:

failing to adequately validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
failing to adequately maintain a device master record;
failing to establish procedures for device history records;
failing to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency;
failing to perform quality audits at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures; and
failing to develop, maintain, and implement written Medical Device Reporting procedures.

Grams was told to take prompt steps to correct the violations and to respond with a list of specific actions taken, documentation of each action, 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

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