FDA 483 & Warning Letters

15 business days to respond to a FDA 483 - Time is of the essence

FDA 483 & Warning Letters

The inspection is over and the FDA Inspector is presenting you with their findings. Your next steps are critical to your business: manufacturers who are not prepared to respond to observations cited on FDA’s Form 483 quickly and thoroughly may receive a Warning Letter. The following check list for dealing with FDA 483s is designed to help you avoid a Warning Letter.

Vision28 Checklist for dealing with FDA 483s

FDA Inspection Close-out Meeting

  • FDA Inspector will issue you a Form 483 listing what the inspector believes are serious objectionable conditions found during the inspection.
  • Ask questions until you understand all of the FDA inspector’s 483 observations.
  • No not argue with the inspector, be courteous and professional.
  • No need to annotate the 483 with “promise to correct”.
  • Do not promise actions, you need to think through the ramifications of all of your choices.

Responding to the FDA 483

  • Start working on your 483 response right away, you only have 15 business days to respond.
  • For contingency scheduling, its best to be prepared to respond in 15 calendar days.
  • Do not over promise.
  • Do limit the response only to what was specifically cited and systemic corrections that would be expected by FDA to prevent future problems in this area.
  • Ensure your responses are limited to actions required to fulfil the regulations; no “nice to haves”.

Writing the response

  • Make clear you are taking the observations seriously.
  • Address all of the observations.
  • Give detail descriptions of the corrections you are making.
  • Make corrections immediately if possible, and include in your 483 response the evidence that you corrected and verified the correction to the observation.
  • FDA will follow up each response in their next inspection, so always do exactly what you said you would do.  They will check to make sure you did not revert back to practices that caused the original observation.
  • Provide FDA realistic schedules for corrections you cannot close out in the response.
  • FDA will require monthly updates of your scheduled corrections.
  • FDA will find any inconsistency or misleading statements in your response, and will “pull the thread” until everything unravels.

Escalation of FDA Responses

  • If you do not respond to the FDA 483, or your response shows you do not take FDA seriously, or if you respond inadequately, the next step is a Warning Letter.  Warning Letters are public information available to your customers and your competitors.
  • If your response to the Warning Letter is inadequate, the next step is a consent decree.  This is a legal agreement between you and FDA overseen by a federal judge.  Companies agree to consent decrees to avoid litigation.
  • Needless to say, you want to avoid a Warning Letter!

Vision28 can help you chart a course for success

It does not matter how you got here, what matters is how you manage the situation.  Impulsive responses lead to bad judgments and mistakes. To effectively manage the situation, you need to plan for success.  We suggest you contact us immediately so that we can help you manage the situation and chart a course for success.  We will work with you to write an appropriate response, structure it in a format FDA expects, and submit it before the deadline.

To ensure the next inspection goes well, we also recommend that you have Vision28 conduct a mock inspection after you’ve remediated the observations as described in your 483 response.  We will examine each response and verify you have done exactly what you said you would do.  We will then communicate the results of this inspection to the FDA as part of your close-out letter, thereby demonstrating that you’ve taken the 483 seriously and you’ve had a third party come in to help you remediate.

A 483 does not have to lead to serious business interruptions. You just need to have the right partner to work through what needs to be done.