FDA Forms Flashcards
Learn all of FDA Forms and what they are used for
1
Q
FDA Form 482
A
Notice of Inspection
2
Q
FDA form 483
A
Inspectional Observations
3
Q
What are “Inspectional Observations”?
A
List of observations made by FDA representative who is conducting inspection of facility
4
Q
FDA Form 1572
A
Statement of Investigator
5
Q
FDA Form 3454
A
Certification - Financial Interests and Arrangements of Clinical Investigators
6
Q
FDA Form 3455
A
Disclosure - Financial Interests and Arrangements of Clinic Investigators
7
Q
FDA Form 3500
A
For Voluntary Reporting of Adverse Events and Product Problems
