FDA 483 / Notified Body nonconformance responses

  • Determine appropriate responses to findings/nonconformances from Letters to File up to and including full Product Recall projects, as needed
  • Develop all levels of remediation activities up to and including the leading of remediation projects
  • Craft responses that contain all required elements.

Warning Letters

  • Determine scope of warning letter and appropriate corrective actions needed to remediate the subject of the warning letter
  • Ensure that the body of warning letter responses contain all required elements to adequately response to FDA
  • Develop and/or lead remediation activities to fully answer and comply with Warning Letter requirements.

Consent Decrees

  • Provide thorough information to FDA according to requirements of consent decree
  • Develop systems and processes to ensure consistency in information and objective evidence provided to the FDA
  • Provide battle-tested FDA liaison experts that can ensure that all communications with the FDA meet legal requirements and stay focused on required information.

Neozene, as your Remediation partner can help you answer the following questions:

  1. The FDA investigator just left my facility and has issued a 483 with five findings. What is my next step?
  2. What is the difference between a 483 and a Warning Letter?
  3. When would I expect to receive a 483, a warning letter, or a consent decree?
  4. I just received a Warning Letter. What am I required to do now?
  5. I was told that my response to my Warning Letter was insufficient. What do I need to do now?
  6. Our company has just been issued a Consent Decree? Do I have to close my doors?
  7. What does a Consent Decree mean, exactly?
  8. How do I best set up my documentation systems to support my Consent Decree?