FDA Forms

Question 1

FDA Form 482

Answer 1

Notice of Inspection

Question 2

FDA Form 483

Answer 2

Inspectional Observations

Question 3

FDA Form 1572

Answer 3

Statement of Investigator

Question 4

FDA Form 3454

Answer 4

Certification – Financial Interests and Arrangements of Clinical Investigators

Question 5

FDA Form 3455

Answer 5

Disclosure – Financial Interests and Arrangements of Clinical Investigators.

Question 6

FDA Form 3500

Answer 6

For Voluntary Reporting of Adverse Events and Product Problems.

Question 7

FDA Form 3500A

Answer 7

For use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting.