Understanding USFDA Form 483: Everything You Need to Know

Introduction to USFDA Form 483

USFDA Form 483, often known simply as "Form 483," is a critical document in the pharmaceutical and biotech sectors. Issued by the U.S. Food and Drug Administration (USFDA) after inspections, this form highlights observations regarding potential violations of the Federal Food, Drug, and Cosmetic Act. For companies regulated by the USFDA, receiving a Form 483 requires immediate attention and action. This article delves into what Form 483 is, and why it is issued?