Fareva Amboise – 09/16/2025. Country: France. Record Type: 483
Similar Posts
Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readingsLearning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.Sanofi S.p.A. – 05/22/2023
Sanofi S.p.A. – 05/22/2023. Country: Italy. Record Type: 483FDA 483, dated June 11, 2008, (9 pages)
FDA 483, dated June 11, 2008, (9 pages)Heparin Importation
Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.
