5 “Don’ts” when it comes to responding to a Form 483
As a leader in Quality and Regulatory Compliance in the Life Sciences industry, you are constantly striving for excellence to provide the highest quality products to patients. However, despite your best efforts, a Form 483 may very well show up on your desk one day. If you’re reading this blog, you are likely familiar with the concept of a Form 483. For those who are not, in short, it’s a list of observations issued by the FDA following an inspection of your facility. If addressed in the right way, a Form 483 can be a bump in the road that you can move on from quickly. If addressed in the wrong way, you can find yourself in a deep hole with potentially disastrous consequences.
With that in mind, here are 5 “Don’ts” when it comes to responding to a Form 483:
1. Don’t Panic
Keep in mind that a Form 483 represents inspectional observations, not a formal determination of non-compliance. Is it serious? Yes. Does it warrant your full, undivided attention? Yes. But if you proactively address it in a timely manner, with diligence and attention to detail, you’ll greatly minimize or eliminate any negative repercussions. Therefore, stay calm. Your employees will be looking at you for leadership, reassurance, and clear communication. You’ll need your people fully focused on the task at hand so if you contribute to an atmosphere of stress and chaos, you’re only failing your team and your company.
2. Don’t Guess
A Form 483 represents the opinions of the FDA inspector on site, and such opinions may need to be further explained and clarified. Do not let the inspector leave your facility without first sitting down and reviewing each observation. You need to be 100% certain (not 99%!) that you fully understand each observation. Making guesses, even educated guesses, as to what is meant by an observation is risky and unwise. So, speak up and ask questions. In addition to getting the answers you need, you will also demonstrate to the inspector that you are taking this very seriously. While getting clarification, don’t hesitate to respectfully challenge the inspector if you believe the observation is inaccurate or misleading. A key word in the last sentence is “respectfully”. Don’t be angry and don’t get personal. Questioning the specifics of an issue – that’s fine. Questioning the inspector’s IQ – not recommended.
3. Don’t Wait
Your response to a Form 483 should commence the day you receive the notice. As stated above, there’s no need for panic, but let’s face it… you need to get moving. You must respond within 15 business days, but if you can get it done earlier, even better. The quicker the FDA can review your responses and planned remediation, the better your chances are to avoid escalation of the issues. But, at the same time, never let your desire for speed impact quality. You should submit a formal written response that is very thorough, demonstrates an understanding of the regulations, and is reviewed by all key stakeholders. All of this takes time… so get started!
4. Don’t Go it Alone
No one is questioning your abilities and determination, but you can’t address a Form 483 by yourself. It goes without saying that you’ll need to bring in others from your team, but it likely needs to extend beyond that. You need to be moving quickly and effectively, so the more people that can contribute, the better. Get the top executives in the loop immediately and get your legal department involved (let them decide if they want to consult external counsel as well), and consider individuals from other departments who can assist. Evaluate your resources to determine if you have the right skills sets to effectively respond to the Form 483 and to develop and execute the necessary corrective actions. Consider bringing in external resources to provide expertise or simply to provide more arms and legs to ensure things move along appropriately. Now is not the time to try to save a few bucks. If you need more help, get it.
5. Don’t Overcommit
Your response to a Form 483 should include specific actions and timelines for completion. While your response certainly needs to demonstrate commitment and urgency, be careful to manage expectations and set realistic, achievable targets. Do not include any actions and timelines that you are not completely certain that you will reach. You’ll never be faulted for doing more than what is documented in your response or finishing sooner, but you don’t want to find yourself explaining to the FDA why you didn’t meet a commitment noted in your response. Just be sure to proactively and transparently communicate with the FDA, explain the rationale for your timelines, and clearly demonstrate progress.
Upon receipt of a Form 483, your daily life will certainly change for a period of time. You will now have a full-time job on top of your normal day-to-day responsibilities. An inadequate response can lead to very serious ramifications including fines, penalties, plant shut-downs, loss of business, consent decrees, and reputational damage. Consequently, an effective and timely response and remediation will become your company’s number one priority. Be mindful of the potential pitfalls noted above and know that Form 483s are not uncommon. Many companies have received them and successfully addressed them… and so will you.
