Published on March 14, 2014
Warning Letter Responses Tips on building the best response and what responses to avoid.
What is a Warning Letter A Warning Letter is a formal notice of significant violations. Given its prominence and effect on industry it is commonly called the first enforcement tool used by the US FDA. First step in taking enforcement action. Indicates a serious violation of statute or regulations Only 15 days to respond. A poor response can drag the process out. A poor response can also lead to additional enforcement actions.
Responses to Avoid Avoiding acting like a stooge. Don’t give the impression you don’t understand the issues. One of the most common responses given. Three Stooge Response Attributes Hasty Dismissive Vague General The Remedy: Provide a specific response to each observation detailing how it can be remedies. Be on time, but be thoughtful.
Responses to Avoid Avoid an angry response. You waste precious time and risk a relationship with the regulators when you fire off an rage-filled response. One of the most difficult responses to remediate. Anger Mgt Response Attributes Free Speech Other Rights Avoids Observations Attacks Agency The Remedy: The FDA can work for you or against you. An angry response risks precious regulatory capital. Be cool, calm, and specific. If there are legal challenges verify with an expert.
Responses to Avoid Do you remember Urkel’s tag-line from the 90’s show Family Matters? “Did I do that?” Claim responsibility and pivot to how the issues are under control. A leading contender for the most common response. The Urkel Response Attributes Claiming Ignorance Confusion Clueless About Regs No Plan of Action The Remedy: This response is given in the hopes the FDA will either take pity or provide a free-pass. Instead it gives the Agency the impression the facility is out of control. An assertive and specific response is the best remedy.
Tips on Responding There are a few basic steps you can follow if you decide to reply on your own. Remember it almost every case it saves money to respond through counsel than fumble a Warning Letter response. Be specific and address every issues raised. Address the Issues Develop a plan of concrete steps to remediate the issues. Plan Ahead Convey your plan and timeframe to the Agency. Communicate Determine how often to provide updates and stick to the schedule. Stay in Touch
Warning Letter Statistics The number of warning letters continues to grow each year. Consider only 673 warning letters were issued in 2010. Total Warning Issues Fiscal Year 2013 Where are all the other warning letters? The Center for Tobacco products received an astounding 6,052 warning letters. The surge in warning letters is likely over confusion about e- cigarette regulations. Food Food and Dietary Supplements make up this category. Medical Device The medical device industry received the 3rd highest number of warning letters Drug and Vet Products Even combined these two categories don’t match food or medical device. 130 217 275 6760
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