The Form FDA 483 is a list of observations made by an FDA official during the closeout meeting of an inspection, all of which must be officially addressed one-by-one.
Although it’s not a final decision on your compliance status, if your organization is issued a 483, it should follow up by undergoing a Corrective Action Plan (CAP) to avoid possible disciplinary action by the FDA.
In almost all cases, the first step in a CAP is to craft a complete and thorough FDA 483 response. To help guide you through the process, we’ve compiled ten of the most important elements all 483 responses should include.
An effective introduction clearly states your organization’s intention to comply with all federal regulations.
A well-written FDA 483 response not only makes it clear your organization is working to improve, but is committed to adhering to those improvements in the future. When stating your intent to comply with federal law, make it clear that compliance is the top priority among the leadership in your organization.
When stating your intent to comply with federal law, make it clear that compliance is the top priority among the leadership in your organization.
Following a clear and concise introduction, it’s important to address and analyze each of the findings and/or observations individually. This is key for two reasons. First, it assures the FDA you understand the why the findings were made, and second, it shows your organization has taken the time to assess the observations in full.
First, it assures the FDA you understand the why the findings were made, and second, it shows your organization has taken the time to assess the observations in full.
This speaks directly to what the FDA is looking for in your response: improvement and enhancement. When explaining the particular
When explaining the particular actions you’re taking to remedy the problems highlighted in the 483, be sure to frame these enhancements by explaining how they will prevent recurrence of the issues in the future. The importance of this point can’t be understated.
This is particularly important if the findings identified competence issues within your staff. While it’s one thing to explain what your company intends to do to fix something, your enhancements must be supported by a clear explanation of the training that will accompany it.
While it’s one thing to explain what your company intends to do to fix something, your enhancements must be supported by a clear explanation of the training that will accompany it.
How you intend to ensure your Corrective Action Plan is followed is another important point the FDA will be looking for in your 483 response.
After describing your enhancements, take the time to lay out a clear system for monitoring not only that the plan is followed, but also that it’s effective.
While it’s important to include any additional documentation that supports your enhancements, don’t overwhelm the inspector with a stack of paperwork.
Include only what helps explain the points made in your response.
If you believe any of the findings or observations came as a result of a misrepresentation during the inspection, politely state your position on the matter along with compelling reasons why clarification is necessary.
Lastly, inspectors will want to know exactly when you intend to actually carry out your CAP. Be extremely cautious not to overpromise and under deliver.
It’s far better to give yourself slightly more time than you think you need to make enhancements rather than set unreasonable expectations for yourself.
While all the items above should be included in your response, this final point highlights the one thing you should never include: an admission of guilt. While it’s perfectly reasonable to acknowledge the findings made by the inspector, don’t issue any kind of formal or informal apology.
Receiving an FDA 483 form can be extremely stressful for any organization, but it doesn’t have to mean harsh penalties and consequences.
Crafting a complete and compelling CAP and following through accordingly is the best way to prevent further action from the FDA.
Have you received an FDA 483 or worried you might in the near future? We can help you plan and create the kinds of corrective action plan the FDA is looking for. Our experienced consultants will provide personalized services to fit your unique needs. Click here to contact us today and grab our free whitepaper explaining an effective compliance remediation project.