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How to respond to an FDA 483 observations?

FDA 483s are forms that the FDA uses to document observations they make during an inspection of your facility.
FDA 483s are the observations found during the inspection of a pharmaceutical manufacturing facility. These observations are documented on a form known as form 483. After getting a notice from FDA on form 483 manufacturing facility has to respond to FDA about the actions taken on the observations. It is not a difficult task to respond to FDA if you have a plan.

FDA 483: The Purpose and Process

Form 483 are issued when FDA found that any pharmaceutical manufacturing has some problems that may affect the product quality. A form 483 does not mean that firm violates the FDA regulation but it indicates the problems that need attention and may cause serious problems in future if not addressed.

Once you have taken the action on the observations on form 483 and notify the FDA in writing that you have taken necessary corrective action then they will not take any further regulatory action.

FDA 483 Checklist

When your firm receives an FDA 483 check the following points before taking any action.
1. Check if FDA has released any guidelines on the observation.
2. Read and understand the guidance properly.
3. Make sure that all documents are available according to the guidance.
4. If you are not sure for something in observations, ask for clarification from the FDA inspector via email.
5. Determine what needs to be corrected.
6. Make necessary correction according to the observations and submit the plan to the FDA.
7. Follow up the FDA that they are satisfied with the action plan proposed by you.

How to Respond to an FDA 483

1. Review the form 483 carefully and note the areas of noncompliance.
2. Determine the observations if those are valid and need corrective actions.
3. Create an action plan to correct the deficiencies observed in form 483.
4. Implement the plan and take corrective action.
5. Notify the FDA in writing about your corrective actions within the 15 working days.

Steps to be Taken After Receiving an FDA 483

1. Review the Observations

Review the observation to understand what exactly FDA observation means and what is required to do to address the observation.

2. Create an Action Plan

After reviewing the observations properly, create an action plan to deal with each observation. This action plan should be created after discussing with the concerned departments. Share this action plan with management and staff so that all can know the ways to deal with the observations.

3. Implement the Changes

After the preparation of the action plan, it is time to execute the plan to address the FDA observations. It may require to change some procedures, process or some time changes in product. But changes made to address the observation should not create a new problem and should not become a cause for further observations. Therefore, changes should be made carefully.

4. Monitor your Progress

After implementation of change plan, you should monitor the impact of change and that should be positive. The addressed problem should be rectified and similar problem should not occur again.

5. Communicate with FDA

After making the necessary changes to address the observation in form 483, you should communicate the FDA to let them know about the changes made by you to address the observations. Due to this communication a trust shall be built between your firm and FDA and they shall not inspect the facility frequently.

It is important to take immediate necessary action after receiving the FDA form 483 in order to address the observations. All observations should be addressed and rectified within a short span of time and your action should be communicated with FDA time to time. A final detailed status report should be submitted to FDA after completion of action plan within a time frame of 15 working days.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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