FDA Forms

Question 1

What is FDA Form 482(d)?

Answer 1

This was previously known as the “Notice of Inspection”, and is now known as “Request for FVSP Records”. This gives FDA authorization to request records to inspect and/or inspect an establishment involved with food, drugs, cosmetics, tobacco products, devices.

Question 2

What fields are on FDA Form 482(d)? Hint: there are 7 groups listed.

Answer 2

1. FDA district office address & phone #
2. Name & title of individual at establishment to be inspected 3. Address & name of establishment/firm
3. Dates/times of inspection requested
4. List of items needing review/inspection
5. Contact email address
6. Name, title, & signature of FDA officer/agent requesting the inspection

Question 3

What section of the Federal Food, Drug, & Cosmetics Act does FDA Form 482(d) pertain to?

Answer 3

According to updated form through FDA website, it pertains to Section 805 and 21 CFR; according to CCRP study manual, it pertains to Section 704(b) and 21 CFR.

Question 4

What is FDA Form 483(a)?

Answer 4

This form contains any observations from establishment/records inspections and is given to the owner/representation of the inspected establishment as a report to help assist them with compliance of FDA regulations.

Question 5

What fields are on FDA Form 483(a)? Hint: there are 8 groups.

Answer 5

1. FDA district office address & phone #
2. Name & title of individual at establishment to whom the report is given to
3. Date(s) of inspection/records request
4. FEI #
5. Firm/establishment name, type, & address
6. Listed observations
7. Name, title, & signature of FDA officer/agent who conducted inspection
8. Date the report was issued

Question 6

FDA Form 483(a) pertains to Section _____ of the Federal Food, Drug, & Cosmetics Act according to the updated form, and Section ____ according to the CCRP manual version.

Answer 6

805, 704(b)

Question 7

What is FDA Form 1572 used for?

Answer 7

This is called the Statement of Investigator, and is required by each investigator intending to conduct a study with an investigational drug. It is a commitment by the investigator to conduct & supervise the listed investigations, and are in compliance with the study protocols, and regulatory requirements.

Question 8

What part of 21 CFR does FDA Form 1572 pertain to?

Answer 8

21 CFR part 312, investigational drugs

Question 9

What is required on FDA Form 1572? Hint: there are 7 groups of items.

Answer 9

1. Name & address of investigator (attached CV or other statement of qualifications)
2. Name(s) & address of where investigations will occur, including labs, radiology, pharmacies, clinics, etc.
3. Name & address of responsible IRB
4. Names of sub-investigators
5. Names & code #s for any IND protocols
6. Protocol info
7. Investigator signature & date

Question 10

What are FDA Form 3454 & FDA Form 3455 used for?

Answer 10

In accordance with 21 CFR 54, these are used for financial interest certification, and disclosure, respectively. These are completed by the sponsor regarding any financial interests or arrangements between them and investigators, along with supporting material as needed.

Question 11

What is FDA Form 3500?

Answer 11

Voluntary reporting of adverse events, product problems, or product use errors. Must include patient info, event/problem details, any devices/meds/etc. that were involved, & info about the reporter.