Despite boasting a new owner, the Indiana manufacturing plant Novo Nordisk picked up as part of its parent company's Catalent ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval decision in 2023. In November 2024, the FDA also found quality control lapses ...

The FDA classifies this recall as Class II, which the agency describes as a situation "in which use of or exposure to a ...

This article focuses on practical strategies for medical device companies to strengthen their quality management systems and ...