1 | Page
Food and Drug Administration Questions
and Correct Answers
Food and Drug Administration Ans: — Enforces regulations to
endure safety and efficacy of biologics and drugs and devices that
include blood/components and diagnostic reagents used or
manufactured.
Administrative and Legal Sanctions Ans: — Address deviations
from regulations and violations of laws: license suspension or
revocation, warning letters, seizure, injunctions, and prosecution
and consent decree
Code of Federal Regulations Ans: — The "legal arm" that mandates
adherence to current GMPs by following SOPs. These are US code
and not a specific entity. This gives FDA the power to impose
sanctions on and entity of facility.
CFR Ans: — 50 titles
Title 21 Ans: — Food and Drugs
Chapter 1 (200-299 & 600-799) Ans: — cGMP
200 Series Ans: — Drugs
600 Series Ans: — Biologics
Center for Biologics, Evaluation, and Research Ans: — Issues
federal licenses for establishments and the biologic products they
manufacture and conducts inspections
FDA Blood Product Deviations and Reporting Ans: — Prompt
notification of any accidents in manufacturing or processing of
blood reported to: Blood bank director, Armed services blood
program director, and FDA.
Report Ans: — Should include: mislabeling, mistyping,
shipping/receipt of improper labeled units, test interpretation
errors, repeated reactive units, units received that were
temporarily or permanently deferred.
© 2025 All rights reserved
Food and Drug Administration Questions
and Correct Answers
Food and Drug Administration Ans: — Enforces regulations to
endure safety and efficacy of biologics and drugs and devices that
include blood/components and diagnostic reagents used or
manufactured.
Administrative and Legal Sanctions Ans: — Address deviations
from regulations and violations of laws: license suspension or
revocation, warning letters, seizure, injunctions, and prosecution
and consent decree
Code of Federal Regulations Ans: — The "legal arm" that mandates
adherence to current GMPs by following SOPs. These are US code
and not a specific entity. This gives FDA the power to impose
sanctions on and entity of facility.
CFR Ans: — 50 titles
Title 21 Ans: — Food and Drugs
Chapter 1 (200-299 & 600-799) Ans: — cGMP
200 Series Ans: — Drugs
600 Series Ans: — Biologics
Center for Biologics, Evaluation, and Research Ans: — Issues
federal licenses for establishments and the biologic products they
manufacture and conducts inspections
FDA Blood Product Deviations and Reporting Ans: — Prompt
notification of any accidents in manufacturing or processing of
blood reported to: Blood bank director, Armed services blood
program director, and FDA.
Report Ans: — Should include: mislabeling, mistyping,
shipping/receipt of improper labeled units, test interpretation
errors, repeated reactive units, units received that were
temporarily or permanently deferred.
© 2025 All rights reserved
