CTBS Regulatory Standards 4

Question 1

What is the purpose of an Establishment Inspection Report (EIR) issued by the FDA following a tissue bank inspection?

Accepted Answer

To document the findings of an FDA investigator during an inspection

Answer

An EIR is the official FDA document summarizing the observations and findings of an FDA investigator during a facility inspection.

Question 2

Which form does the FDA use to communicate objectionable conditions observed during a tissue bank inspection?

Accepted Answer

Form FDA 483

Answer

Form FDA 483 (Inspectional Observations) is issued to the tissue bank's management at the close of an inspection to list objectionable conditions found.

Question 3

Under 21 CFR 1271.60, what is required before a tissue establishment changes ownership?

Accepted Answer

The new owner must file a new establishment registration before beginning operations

Answer

When ownership of a tissue establishment changes, the new owner must register with FDA as a new establishment before resuming operations.

Question 4

Which of the following is NOT a criterion for classifying an HCT/P as a 361 product regulated solely under the PHS Act?

Accepted Answer

Manufactured in an ISO 7 cleanroom

Answer

Cleanroom classification is a manufacturing control but not one of the four regulatory criteria that determine 361 HCT/P status under 21 CFR 1271.10.

Question 5

Under AATB Standards, which professional is responsible for making the final donor eligibility determination?

Accepted Answer

The Medical Director or designated physician

Answer

AATB Standards assign final donor eligibility determination to the Medical Director or a designated licensed physician, ensuring medical accountability.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Regulatory Standards 4