This post is sponsored by Regulatory and Quality Solutions, LLC.
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 five 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.
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 Preventative 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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.
For five more tips, go to our website at http://raqasolutions.com/resources/warningletters
