Has your company received an FDA warning letter? The FDA will issue a warning letter notifying you if they find a violation or non-compliance regarding your device. These letters indicate serious issues and require a prompt response. Failure to respond can lead to fines, injunctions, product seizure or recalls, and more. Common issues that result in FDA warning letters include:
- False or inadequate labeling
- False or incorrect instructions for use
- False or unsubstantiated medical claims
- Medical claims for an unapproved product
- Failure to obtain a marketing authorization from FDA
- Incorrect or undocumented design controls or manufacturing processes
- Non-compliance with written procedures
- Misbranded or adulterated products
The FDA warning letter will state corrective actions required, a timeline to complete them, as well as the consequences of failing to comply with the letter. You have a limited time to respond to the letter and it is critical that your response is satisfactory. Sterling’s regulatory experts have helped countless companies with FDA warning letter responses. We’ll help you quickly respond to the letter and address the listed violations.
FDA Warning Letter Support:
We will accompany you through the complexities of the FDA warning letter, ensuring you act quickly and proactively to resolve the regulatory issues in question.
With our Regulatory Support Services, we’ll partner with you to:
- Analyze the contents of the FDA warning letter
- Draft a response to the FDA
- Develop a plan to address the issues
- Create a timeline for implementation
- Lead or assist in the implementation of the plan
- Field questions from you or the FDA during corrective action activities
Turn it over to Sterling
With our Regulatory Support Services, you get a partner with decades of experience helping clients achieve and maintain regulatory compliance. Let us help you keep your device on the market, and rest easy knowing you’re in capable and experienced hands.
To learn more about how Sterling can help you address FDA warning letters, fill out the form above.
