Sample FDA 483 Response Format – The Cover Letter
When initially formulating a FDA 483 response, a 4-Stage Inspection Response Approach may be helpful to develop perceptive on the format of the response and contribute to a better understanding of what actually needs to be implemented to be compliant. This type of approach includes 1) restating the observation, 2) Defining Root Cause, 3) Indicating Corrective Actions and 4) Developing a Due Date.
If this approach is completely followed, any corrective actions will be systemic as they should address the root cause(s) defined. This will also aid in the development of due dates as the firm will be more informed as to what actually need to be accomplished.
FDA 483 Response Format – Cover Letter
We are in receipt of your communication dated — on —–. We take your communication very seriously and commit ourselves to address your concerns adequately and expeditiously. We will take all the necessary measures to ensure our customers’ well-being and safety. Enclosed please find an attachment that addresses your concerns on an individual and on a systematic basis.
We agree that a sound Quality System is the result of effective management commitment, dedicated employees, and sound processes and practices.
To that end we have retained _____, a reputable consulting firm, to assess our Quality System in greater detail and to help ensure that our Corrective Action plan will address all systemic issues effectively. We have attached a qualification profile for your review.
We have already taken the following immediate corrective actions to remediate potential urgent concerns as follows:
[Describe here in brief these corrective actions.]
Additionally, we have chartered a Management Action plan staffed with expert individuals to develop long-term corrective actions. This plan is attached for your review. You will find that we have prioritized our next set of actions based on the risk assessment of your concerns. The plan includes the specifics of our actions along with targeted timelines. We will closely monitor the implementation of this plan and will provide you with updates on our progress on a monthly basis along with evidence of implementation. Should we change any of our commitments, we will provide you with our reasons and supporting documentation.
We also intend to monitor the effectiveness of our corrective action plan on a long-term basis.
We believe that this comprehensive Corrective Action plan will successfully rectify all deficiencies described by your communication and will make our company even stronger and more effective in meeting GMP compliance.
We would like to request a review of our plan and invite your feedback as to its adequacy. We also remain available for any phone consultations or personal visit to your offices should that be necessary.
Feel free to contact Mr. _____ at ______, if there are any concerns with our response.
Free FDA 483 Action Package
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