Responding to an FDA Form 483: A 5-Step Approach.
We use the following five-step approach to guide our clients through the Form 483 response process.
Step 1: As an experienced regulatory compliance executive, use the closing meeting with FDA investigators to clarify findings outlined in a Form 483. You need to fully understand the basis for each finding and gather as much specific information as possible while investigators are on site.
Step 2: Assemble a response team comprising representatives from the departments or areas where findings were identified in the 483. Review the Form 483 findings as a team and make sure that everyone is interpreting the observations in the same way. Assign a subject matter expert (SME) lead and author to each observation. Focus on identifying the root cause of each observation. Depending on the citation, that may take some careful detective work.
Step 3: The FDA requests that a company respond to a 483 within 15 business days and offer a plan to address the observations.
Step 4: In your response to the FDA, address each finding separately. Describe the root cause behind the finding and the corrective actions to be taken. Be realistic when describing the timeline requirements for remedial actions.Step 5: Perception is extremely important: You want the agency to understand that your company takes the Form 483 observations seriously and has robust quality systems in place to meet GxP compliance requirements. Finally, use the Form 483 experience as a learning tool, and consider it to be an audit report that you did not have to pay for directly.
