FDA Warning Letter Response

Has your company just received a Warning Letter from the FDA?

Prevent further action by responding now! Time is of the essence!

The dreaded FDA Warning Letter.

You may never have heard of one before, but if you have received one, you now know and are trying to figure out how to handle it. These letters are publicly released via the FDA website and include a listing of violations observed by the agency.

Identifying the violation

A Warning Letter arises when the FDA finds that a person responsible for operations of a regulated firm has significantly violated FDA regulations. The Warning Letter identifies the violation[s], such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

Act Now

Time is of the essencerespond with an adequate plan

The letter also makes clear that the company must correct the problem and provides a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections or corrective action plan are adequate in response to the violation.

The FDA typically gives 15 business days to respond with an adequate plan. The best option is to try and mitigate by taking as many actions as possible in the quickest amount of time.

15 business days to respond to a public Warning Letter
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Our skillfully trained attorneys are ready to help

Getting a public Warning Letter from the FDA can be detrimental to your business, but even worse is not responding or responding inadequately and having your operations shut down. Not to worry, our team can guide your response strategy and provide guidance on immediate corrective actions you can take right now. Don’t wait, call us today.

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We strive to ensure that our clients are educated about the processes of becoming compliant and understand our role in the process. Hiring an FDA regulatory attorney can make all the difference when ensuring compliance.

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