FDA forms

Question 1

Form 482

Answer 1

Notice of Inspection (Form 482) is a formal document issued by FDA inspectors to notify a facility that it is being inspected under the authority of the Federal Food, Drug, and Cosmetic Act.

Form 482 is given to a responsible institution representative after inspectors present their credentials, at opening meeting.

Question 2

Form 483

Answer 2

Inspectional Observations (Form 483) is issued if the FDA inspector observes violations or non-compliance with regulatory requirements during inspection. It highlights the need for corrective actions.

From 483 is issued at the end of inspection.

FDA Center determines whether each observation
constitutes a regulatory violation and if so, determines the
impact on data integrity and subject safety

Written response is optional but demonstrates acknowledgment, understanding and commitment to corrections.

Question 3

Form 1572

Answer 3

Statement of Investigator
(No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)).)

• Investigator name and contact
• name and address where the investigation will take place (research facility)
• name and address of clinical lab
• name and address of IRB
• names if Sub-Is
• name and code of INDs

Question 4

Form 3454

Answer 4

Certification: Financial Interest and Arrangements of Clinical Investigator

Attests to the absence of financial interests and arrangements described under “Disclosure of statement”.

• In compliance with 21 CFR 54 (Financial disclosure)
• certification that investigators did not enter into a financial arrangement with the sponsor

Question 5

Form 3455

Answer 5

Disclosure: Financial Interest and Arrangements of Clinical Investigators

Discloses the following:
1. Financial arrangements between the sponsor and the clinical investigator
2. Any significant payments of other sorts from the sponsor
3. Any proprietary interest in the tested product
4. Any significant equity interest in the sponsor
5. Any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments

Question 6

Form 3500

Answer 6

MedWatch: The FDA Safety Information and Adverse Reporting Program

• For VOLUNTARY reporting of adverse events, product problems and product use/medication errors

Question 7

Form 3500A

Answer 7

MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory

• For use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting