Devices

QS Violations at Orchid Orthopedic

A 2/4-2/15 FDA inspection at Orchid Orthopedic Solutions, Farmington Hills, MI, found Quality System Regulation violations in the firm’s work as a medical device manufacturer specializing in applying coatings to orthopedic implants that promote bone ingrowth. A 5/13 Warning Letter says the specific violations were:

failing to establish and maintain procedures to control product that does not conform to specified requirements;
failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
failing to establish and maintain procedures for implementing corrective and preventive action;
failing to adequately validate a process whose results cannot be fully verified by subsequent inspection and test;
failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failing to adequately establish processes for quality audits.

Orchid was told to respond with a list of specific steps taken to correct the violations and prevent those or similar violations from occurring in the future, with documentation of the corrections and/or corrective actions, 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