/ 1 min read / LexisNexis Practical Guidance

FDA Form 483: Inspectional Observations Best Practices for Responding

In this video, FDA Form 483 is discussed, with an emphasis on the best practices for responding to the form. After receiving a 483 response, the FDA will either (1) ask additional questions, or (2) accept the statements made by the company. One best practice is for companies to provide regular monthly updates to the FDA to explain the items that have been addressed since the submission if the company’s 483 response contained open items to be accomplished by a future date.

Authors

Cori Annapolen Goldberg
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