FDA Forms

Question 1

FDA Form 482

Answer 1

Notice of Inspection

Question 2

FDA form 483

Answer 2

Inspectional Observations

Question 3

What are “Inspectional Observations”?

Answer 3

List of observations made by FDA representative who is conducting inspection of facility

Question 4

FDA Form 1572

Answer 4

Statement of Investigator

Question 5

FDA Form 3454

Answer 5

Certification - Financial Interests and Arrangements of Clinical Investigators

Question 6

FDA Form 3455

Answer 6

Disclosure - Financial Interests and Arrangements of Clinic Investigators

Question 7

FDA Form 3500

Answer 7

For Voluntary Reporting of Adverse Events and Product Problems