fda warning letter response
DESCRIPTION
FDA Attorney Marc Sanchez presents best practices in responding to a FDA Warning Letter. He outlines the basics of a US FDA warning letter, responses to avoid and how to build a strong response to Form 483s and Warning Letters.TRANSCRIPT
Warning Letter Responses
Tips on building the best response and what responses to avoid.
What is a Warning LetterA 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 AvoidAvoiding acting like a stooge. Don’t give the impression you don’t understand
the issues.
One of the most common responses
given.
Three StoogeResponse
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 AvoidAvoid 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 MgtResponse
Attributes
Free SpeechOther RightsAvoids ObservationsAttacks 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 AvoidDo 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 UrkelResponse
AttributesClaiming IgnoranceConfusion
Clueless About RegsNo 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 RespondingThere 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 StatisticsThe 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 DeviceThe medical device industry received the 3rd highest number of warning letters
Drug and Vet ProductsEven combined these two categories don’t match food or medical device.
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