3 Parts of an FDA 483 Response (Part-02)
Here are 5 essential things to keep in mind when crafting your response:
1. Be clear
While the details of your response depend on the particular observations cited, it should specifically respond to each observation, be easy to follow and leave no doubt about what you intend to do to resolve the situation.
2. Be compelling
Typically, the most effective way to write your response is in narrative form. State the observation and address it in a clear, chronological format allowing you to put your company in the best light possible.
3. Anticipate potential questions
Your response should first focus on addressing the central issues raised in the observations and provide accurate, objective evidence that anticipates and answers the potential questions your action plan lays out.
3. Carefully manage disputes
Never ignore an investigator’s claims. If you decide to dispute an observation, you must be prepared to back it up with enough factual, objective evidence to be convincing.
4. Support all claims with facts and hard data
Every claim and response you make in your response must be backed up with objective evidence. Unsupported or poorly explained assertions are of no value to the FDA and only raise more doubts about your ability to resolve the problems identified.
5. Assess your response for quality and thoroughness
Proofread, edit and re-work your response before submission to ensure it is as complete and compelling as possible.
