FDA Compliance Group LLC

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

FDA Form 483 Responses ~ FDA Consulting Services

If the FDA has inspected or audited your business or facility and given you a Form 483, with observations related to compliance issues, don't panic...just contact us!

We have an experienced team of ex-FDA and industry consultants who specialize in all aspects of FDA inspections and compliance, and we'll steer you through the resolution process.

Often, a well-written FDA Form 483 can prevent further regulatory action by the FDA, including a Warning Letter, or worse, a rejection of product approval, a product recall, or a plant shut-down.

We'll help you construct a comprehensive response to a Form 483, that:

  • addresses each observation
  • provides a timeline for correction
  • requests clarification of the FDA requirements

FDA Form 483 responses must be submitted within 15 business days, so if you'd like assistance, 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 Form 483 issuances, we also provide mock FDA inspections that mirror full-blown FDA inspections.