Devices

FDA Hits Olympus with Warning Letter

FDA has issued Olympus Medical Systems a Warning Letter after inspecting the firm’s Tokyo facility and documenting GMP deficiencies. According to the 3/15 letter, the 11/2022 inspection cited Olympus for failing to adequately establish and maintain procedures for implementing corrective and preventive actions. It also failed to ensure that when changes or process deviations occur, they should be reviewed and evaluated or revalidated where appropriate.

The inspection also found that Olympus failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Additionally, FDA says the inspection revealed that the firm’s Single-Use Distal Cover devices are misbranded because Olympus “failed or refused to furnish material or information respecting the device” that is required by FDA’s Medical Device Reporting (MDR) regulation. Specifically, it failed to implement written MDR procedures. It also failed to submit an MDR report within 30 days after becoming aware of a malfunction.

FDA has been targeting Olympus recently over GMP issues. Earlier this year, inspections at two Olympus medical device manufacturing facilities also in Japan led to separate Warning Letters (see earlier story). At the time, CDRH director Jeff Shuren noted in a statement that the two Warning Letters are the “most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes. However, as described in the recent Warning Letters, Olympus is not in compliance with MDR reporting and quality system requirements.”

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