3 Parts of an FDA 483 Response (Part-01).
The structure of your response should follow this 3-part outline:
Cover Letter
In this introduction, respectfully thank the FDA for identifying opportunities for continuous improvement and clearly state your obligation to comply with the law through commitment to action. This should be written by senior management.
Body
Restate each observation and include the following for each one:
Background information regarding the observation.
An assessment of the root cause of the problem or commitment for further investigation if additional time is needed, with target dates for completion.
Corrective and Preventive actions immediately corrected if possible with completion dates and objective evidence to be included with attachments or attainable target dates for completion.
List of Attachments
Clearly describe and identify any attachments you provide. The numbers and names referenced in the body should exactly match the number and name in the list. Attachments should be easy to find, read and understand.
