After You Submit Your FDA 483 Response
Without knowledge of the requirements needed to complete the actions, the events following the response will fall into one of three categories:
- Actions needed to finish the task will be completed significantly earlier than the date indicated in the response. The risk here is that the reader of the response will know that it does not take that long and will consider your reaction inappropriate.
- Actions needed to complete the task are performed prior to the date indicated in the FDA 483 response. This position can be great if planned out and performed in a compliant manner. As some have discovered, much to their chagrin, some response time frames are not that well thought out and in order to complete the task necessary, monumental actions have to be taken. This may include significant overtime, hiring temporary staff, not completing routine activities or completing the task with shortcuts or in a non-compliant manner.
- Actions needed to complete the task are performed after the date indicated in the response. Most audit bodies (even governmental auditors) understand that things happen and sometimes tasks cannot be completed in the time indicated. The audit body should be notified immediately (best time is BEFORE the due date of the action). Explain the situation, what has happened, the tasks completed and the new due date. That being said, if missed commitments are frequent enough or happen not once but two or three times, the audit body may become concerned and inquire into the situation further.
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.