After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The FDA Investigations Manual discusses the process for assigning inspections in Chapter 7 – Recall Activities. When the FDA learns of a potentially violative product that may cause or has caused a ...

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...

On Feb. 2, 2024, FDA published its long-awaited amendment to its current good manufacturing practice requirements for medical devices. The new Quality Management System Regulation (QMSR) now ...