Gambro warning letter
This article was originally published in The Gray Sheet
Executive Summary
FDA calls for the detention of Prisma and Prismaflex continuous renal replacement therapy systems and Phoenix hemodialysis machines at the U.S. border in a Jan. 5 letter citing quality system concerns, Gambro announced. The agency conducted a non-routine "for-cause" inspection of the Gambro Dasco unit's Medolla, Italy facility in September. The audit did "not directly" respond to an August 2005 Class I Prisma recall relating to the potential for caregivers to inappropriately override one of the system's alarms, Gambro said...
You may also be interested in...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.