FDA forms Flashcards
1
Q
What is FDA form 482
A
Notice of inspection
2
Q
What is FDA form 483
A
Inspectional Observations
3
Q
What is FDA form 1572
A
statement of investigator
4
Q
What is FDA form 3454
A
Certification - Financial interests and arrangments of clinical investigators
5
Q
What is FDA form 3455
A
Disclosure - Financial interests and arrangements of clinical investigators
6
Q
What is FDA form 3500
A
For voluntary reporting of adverse events and product problems
7
Q
What is FDA form 3500A
A
For use by user-facilities, distributors, and manufacturers for mandatory reporting
8
Q
ALCOA
A
Attributable
Legible
Contemporaneous
Original
Accurate
