FDA Form 483

What is FDA Form 483?

FDA Form 483 is issued when an investigator has observed conditions that may constitute a violation of the Food, Drug, and Cosmetic Act or other Acts and regulations overseen by the Food and Drug Administration (FDA). The FDA investigators only note what they observe during their inspection.

Observations included on the FDA Form 483 are made when, in the investigator’s judgment, practices or conditions observed indicate that a drug or device is being packed, prepared, or held under conditions where it may become contaminated or harmful to health.

After an inspection, the FDA Form 483 is discussed with the company’s management. The FDA investigator goes through the form and discusses each observation with them so that they fully understand what the observations are and what they mean.

How does an FDA Form 483 improve healthcare? 

An FDA Form 483 highlights areas where a company needs to improve its manufacturing process to guarantee the proper preparation, packing, or storage of their product. FDA Form 483 spurs on quality improvement and ensures that the products consumers receive are safe and effective.