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Maria Fagan

Ten Points for Successfully Addressing Warning Letters
by By Maria Fagan, President, Regulatory & Quality Solutions LLC



Jul 10, 2013 | Free Downloads | email | Print

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Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.

Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business, both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not addressed effectively and expediently.

Here are ten common-sense points to remember while establishing a constructive working relationship with the FDA as well as moving forward with better business practices that are balanced and compliant to regulation.

An open warning letter may hold up product submissions/clearances/approval with the FDA or may affect your company’s foreign relations.
  1. Don’t ignore the warning letter. Be sure you really understand its citations. Within 24 hours, make the phone call to the FDA to discuss the issues. Advise the FDA that you’ve received the letter and that you and your team are working to put a plan in place to address the issues.
  2. Carefully assign the best leadership to handle the warning letter. Identify individuals within the organization who are strong project managers to effectively lead the response to the FDA. They should be able to build consensus regarding the actions within your organization and drive those actions. Be mindful of those who may have been responsible for citations issued in the FDA Form 483 and the subsequent warning letter. Determine if you have the appropriate in-house expertise to address the issues; if not, consider seeking experienced and business balanced outside help.
  3. Once you have your leadership team in place, break down the warning letter issues into multiple projects and use your corrective and preventive action (CAPA) system to manage each individually through to the letter’s closure. The FDA wants to know that you are using your CAPA system and that it is effective and functioning well. Receiving FDA warning letter citations is definitely a notice of systemic issues that must be resolved. Your CAPA system is just like the immune system of the body; when it is functioning well, your business will respond in a “healthy” manner with improved quality systems that will drive your business to improved financials.
  4. Assign the best team members to each CAPA. If the warning letter is complex, designate a point person to oversee all activities. Review each finding and ensure your CAPAs will address the underlying root cause or systemic issue, and determine a time frame to implement the Corrective Actions. Within 15 working days of receiving the warning letter, forward to the FDA a detailed timeline for your plan to address the deficiencies noted, ensuring that the response addresses each item in the warning letter.
  5. Court the FDA throughout the entire process with continual communication and regular status reports. Follow through with promises. You know you are on the right track with the FDA when they respond with significant positive communication. Stay on top of all documentation. File and track all records and promises with the FDA.
  6. Expect to spend resources when you get a warning letter. You may want to clear the plates of some management personnel to ensure proper and timely response to the letter.
  7. Don’t let a consulting firm, especially one that is not a focused regulatory consulting firm, be the ultimate overarching lead for the warning letter. While outside consultants and leaders should be brought in to assist with the leadership of the strategy, complete tasks needed to bring the warning letter to timely closure, or to complete the business activities needed to ensure current revenue is not jeopardized, ultimate leadership should be someone from inside who is intimate with your company and its products.
  8. To protect time spent on tasks in support of the warning letter CAPAs and to most effectively utilize assigned resources, make sure detailed information regarding the progress and completion of associated tasks is successfully transitioned if management changes occur. Change happens - do not allow valuable progress to get lost in the transitions.
  9. If your response to the FDA is deemed sufficient, recovery from a warning letter must demonstrate to the FDA that you have learned from the experience, as the FDA will look to schedule a follow-up inspection depending on the corrective action time frame your company submitted. As part of this recovery, conduct a thorough and rigorous mock follow-up audit to evaluate the completeness and adequacy of your corrective action implementations. Consider using a third party for an independent and unbiased assessment.
  10. Once you get the warning letter closed, take time to ensure lessons are learned from this time- consuming and expensive experience. Ensure that a culture of compliance continues to be fostered within your organization so that you are always audit ready. Ultimately, if done effectively, the warning letter improvements should result in balanced business practices which will enhance your business - culturally and financially.

Remember, an open warning letter may hold up product submissions/clearances/approval with the FDA or may affect your company’s foreign relations.

Should the FDA conclude your response to the warning letter is inadequate, their next step – and one you want to avoid- could be to issue a consent decree. A legal agreement enforced by the federal courts compelling your company to make the required specified improvements or changes, a consent decree could drastically alter your company culture. It may include fines, penalties for noncompliance, and deadlines for specific actions or even reimbursements to the government for inspection costs. The agreement could also require your company to stop production, to hire a third party to conduct tests or to delay new product rollout. By taking warning letters seriously and correcting errors as soon as possible, you take large steps toward business success and away from the very expensive, revenue-draining endeavor of consent decrees.



Maria Fagan is President of Regulatory and Quality Solutions, LLC (RQS). Maria has extensive experience in medical device development across regulatory and quality areas as well as post-surveillance and compliance. In 2008, Maria along with partners Lisa Casavant and Robert Markley founded RQS to support their entrepreneurial desires to serve the medical device industry with business balanced, hands-on regulatory and quality expertise so as to accelerate the success of medical device companies and thereby improve people’s lives. Since 2008 RQS has grown to over 30 RQS employees nationally and provides hands-on expertise with over 250 years of combined team experience. RQS provides an integrated regulatory and quality team that provides excellent customer service to their customers. Because of the outstanding RQS team and subsequent fast growth, RQS was named the 4th fastest growing company in Pittsburgh in 2012. RQS focuses keenly on customer and team member satisfaction as well as community involvement. RQS Cares has been established to provide formal avenues for RQS to give back to the community. For information about RQS Services or employment opportunities, call Maria Fagan at 724-327-0230 or visit the company’s website at www.raqasolutions.com.


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