The FDA's Clock Is Ticking – Why Those 15 Days Are Critical

When many companies respond to an FDA 483, they tend to address each specific violation in their response letter. Although they are addressing the individual complaints, they never actually get down to solving the underlying problems.

Developing a response letter that addresses the inspectional observations as well as the underlying problems has gotten more challenging. The agency is now putting more pressure on drug manufacturers to answer within 15 workdays after an inspection closes out. The clock is ticking, and your time is running out!