by Dr. Yashashwini Reddy | Sep 6, 2025
The Importance of FDA Form 483s and Warning Letters in Pharmaceuticals 1. What is FDA Form 483? FDA Form 483, “Inspectional Observations,” is issued by FDA inspectors to company management at the end of an inspection. It lists potential violations of the Food, Drug,...
by Dr. Yashashwini Reddy | Aug 18, 2025
Why Firms Must Avoid FDA 483 and Warning Letters? Pharmaceutical, biotechnology, and medical device firms must avoid FDA Form 483 observations and Warning Letters because they indicate serious compliance failures that can harm business operations, reputation, and...
