FDA Forms

Question 1

Notice of Inspection

Answer 1

FDA Form 482

Question 2

Inspectional Observations

Answer 2

FDA Form 483

Question 3

Statement of Investigator

Answer 3

FDA Form 1572

Question 4

Certification - Financial Interests and Arrangements of Clinical Investigators

Answer 4

FDA Form 3454

Question 5

Disclosure - Financial Interests and Arrangements of Clinical Investigators

Answer 5

FDA Form 3455

Question 6

For Voluntary Reporting of Adverse Events and Product Problems

Answer 6

FDA Form 3500

Question 7

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

Answer 7

FDA Form 3500A

Question 8

Investigational New Drug Application Cover Sheet

Answer 8

FDA Form 1571

Question 9

Certificate of Compliance

Answer 9

FDA Form 3674

Question 10

Device Listing

Answer 10

FDA Form 2892