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How to Respond to 483 Observation and Warning Letters?

As a recipient of a response warning letter, it is important to follow the basic steps outlined below to ensure a timely and effective response.

1) Acknowledge receipt of the letter through certified mail, informing the FDA that we intend to respond within 15 business days. This initial correspondence should be brief, simply and serve as a notification of our intention to respond by the deadline.

2) Form an action team to address the issues outlined in the warning letter.

This team should consist of key individuals who have a comprehensive understanding of the problems cited and a clear plan for how to resolve them. 

3) Determine a plan of action - Define a list of actions that will be taken to address each of the FDA’s observations and specific examples. 

Evaluating the impact of the violations, removing affected products, implementing new procedures, conducting training, performing audits, seeking expert advice, opening corrective and preventive action (CAPA) plans, providing documentation, and validating methods and processes. It is important to carefully consider each observation and determine the most appropriate and effective course of action.

4) Response: 

Cover letter: It should clearly state who will be the primary point of contact and the designated person signing the response letter. It should also provide a brief overview of the reason for the letter and define any key terms that may be relevant to the response, management's commitment to address any issues raised by the FDA, and if applicable, acknowledge any previous warning letters. It may also be beneficial to request a meeting with the FDA to discuss any systemic deficiencies or potential health risks that have been identified.

Body of the response - to address any systemic corrections that need to be made to underlying issues. This may include corrective actions for specific instances, as well as steps for identifying, examining, and correcting similar problems in the future. It is also important to provide an impact assessment on manufactured products and interim compliance measures that have been put in place. Realistic timelines for implementing these corrections should also be included, along with any attachments that can verify the actions that have been taken.

Attachments such as standard operating procedures, training records, or any other relevant documentation. It is important to ensure that all attachments are organized and clearly labeled for ease of reference.

In Appendix 3, a table of actions and accomplishments should be provided. This can be in the form of a table containing the number of each FDA 483 observation (or warning letter observation) and a brief description of the completed and planned actions, along with a timeline for completion.

Once the FDA is satisfied with the response and any necessary follow-up inspections have been completed, a closeout meeting will be scheduled.

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Resource Person: Bharathi Kodali

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