by Dr. Yashashwini Reddy | Sep 8, 2025
Difference Between FDA Form 483 and Warning Letter 1. FDA Form 483 (Inspectional Observations) Issued when: FDA inspectors observe potential violations of the Food, Drug, and Cosmetic Act (FD&C Act) during an inspection. Purpose: To notify company management of...
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...
