During an USFDA inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

What will you learn

In this course, you will learn some of the following concept

• What are USFDA Inspection Form 483, Form 482, Form 484?
• EIR (Establishment Inspection Report)
• OAI (Official Action Indicated)
• NAI (No Action Indicated)
• VAI (Voluntary Action Indicated)

Language: Hindi

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