What is the role of the FDA’s Form 483?

• A. It is issued after an inspection to document observed noncompliance with regulatory requirements
• B. It is the form used to apply for inspections
• C. It lists approved devices
• D. It is used to request import permits

Answer: (C)

Form 483 is issued at the end of an FDA inspection to document observations of conditions or practices that may violate regulatory requirements. It serves as a formal notice to the firm of what the inspectors observed and areas that may require corrective action. It is not used to apply for inspections, it does not list approved devices, and it is not a tool for requesting import permits. After a 483, the firm can respond with corrective action plans, and depending on the findings, further FDA actions may follow if issues aren’t addressed.