FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

FDA Warning Letter Responses ~ FDA Consulting Services

FDA Warning Letters are nothing to take lightly...they're warnings that the FDA has found that one or more of your practices, processes, or products is in violation of FDA requirements and that the FDA is prepared to take action.

These FDA Warning Letters give you the opportunity to take corrective measures to prevent further enforcement actions.

A well-crafted, thorough response to a Warning Letter can mean the difference between the issue being resolved, or products being seized and facilities being shut down. In addition, FDA Warning Letters are published on the FDA's website and are available for the public to review.

An FDA Warning Letter is typically issued because an issue that was found during an FDA inspection was egregious or because an observation on the FDA Form 483 was never properly addressed.

At FDA Compliance Group, we have FDA consultants who have worked for the FDA for decades and are experts in the compliance process.

If you'd like assistance in responding to an FDA Warning Letter, please contact us immediately.

Please note: We can write FDA Form 483 responses for all FDA regulated industries, including: medical devices, dietary supplements, drugs, clinical trials, and food & tobacco. To help prevent FDA Warning Letter incidents, we also provide mock FDA inspections that mirror full-blown FDA inspections.