On April 16, 2026, FDA’s Center for Devices and Radiological Health (CDRH) issued a Letter to Industry warning manufacturers of CDRH-led combination products about the potential for nitrosamine impurities and outlining what manufacturers should be [...]

FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” It’s aiming at drug manufacturing sites regulated by CDER/CBER/CVM and lays out what FDA expects [...]

Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect [...]