Analyzing the inspection results and committing to action
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address the possible violations in a sustainable way, and how to establish a method to guide the remediation work.