Our team of former medical device executives, who have managed warning letter and consent decree remediations, work with the support of former FDA regulators to understand what the agency expects to see in a response to a warning letter or other regulatory actions.
We start by setting the tone of the conversation—FDA and manufacturers are on the same side when it comes to patient safety and product efficacy. We will help you craft a response with a remediation plan that addresses the FDA’s concerns and helps build trust and credibility.
Responding to an FDA warning letter is an urgent matter, but we understand that your team must also maintain daily operations. RQM+ provides all the support you need to provide a strong response that addresses compliance concerns, avoids additional regulatory actions, and supports business continuity.
Often, the compliance deficiencies identified in FDA warning letters should not be treated as isolated issues. Warning letters can be an accumulation of many years of system, organizational, cultural, and/or operational issues. RQM+ can help your business get to the root cause of these issues and establish a plan to assure these same deficiencies do not arise again. The more proactive you can be about addressing core issues leading to compliance failures, the lower the risk of future warning letters or regulatory actions.
If you receive a 483 and expect it to escalate to a warning letter, we recommend a proactive approach that gives you more time to respond and implement any necessary changes. When you engage RQM+ from the beginning, we can help you develop the appropriate strategy, craft a compelling response, and execute changes as needed.
We have a deep understanding of both the regulations and your business goals. This allows us to craft a risk-balanced strategy that keeps you in compliance, prioritizes product safety and efficacy, and also considers your business needs.
Although both FDA and manufacturers are on the same page about the importance of prioritizing patient health and safety, we know that there are multiple pathways for getting there. In addition to setting the right tone for the response, we will also help you justify your approach when addressing the concerns outlined in the warning letter.
If any process or system changes are required as a result of the warning letter, our team can help you execute all of the necessary tasks to achieve and maintain compliance. Whether you need support with quality, manufacturing, or risk management systems, we have project managers and skilled teams with the required expertise.
Although it is possible to handle an FDA warning letter response on your own, when you work with RQM+ your business gets lasting benefits.
Deep industry knowledge and regulatory experience give us insight into what regulators are looking for in a warning letter response.
We will work closely with your team to develop the best response strategy based on your specific business needs, product portfolio, risks, and goals.
Our proactive approach not only results in immediate solutions to satisfy the FDA but also lasting changes that improve your overall business.
Our team has truly seen it all, and with every warning letter response, we update our internal systems to incorporate all of the lessons learned.
“Good enough” is difficult to define, but it needs to be tied to risk. The best way to start is to look at safety and compliance risk using existing guidance. Also, doing a gap assessment of the documentation, ranking the gaps by risk level, and aligning with your risk management process will help you get toward developing a remediation plan and strategy and communication with regulators.
First, build out a clear traceability matrix by mapping inputs to outputs, design verification, evidence. Also, focus on quality over quantity. Do not get bogged down by spending all your time on the smallest part of the fix. You do not have to address every single potential wrong turn, instead focus on the big stuff that is happening, is in your complaints, and is in your CER.
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