What is the difference between 483 and warning letter
What is the difference between 483 and warning letter
Replies to this topic (1)
2025-07-25 02:50:35
483 - means FDA inspection letter which contains observation
Warning letter means if you will not be able to give the justification or answer for 483 , then warning letter will be issued.
After getting warning letter FDA will give you time to clear all issues and they will come again to check all implementation inline with our response or not.
Still you are not meeting the requirements means they will give the import alerts
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