Food and Drug Administration

21 CFR

200 & 600 Series

CFR

50 titles

Administrative and Legal Sanctions

Address deviations from regulations and violations of laws: license suspension or revocation, warning letters, seizure, injunctions, and prosecution and consent decree

600 Series

Biologics

FDA 2609

Blood bank inspection checklist and report

Current GMP

Comprehensive directive found specifically in CFR 21 parts 210 and 211

FDA

Inspection and Instructions booklet

Center for Biologics, Evaluation, and Research

Issues federal licenses for establishments and the biologic products they manufacture and conducts inspections

FDA 483`

Notice of inspection observations

FDA Blood Product Deviations and Reporting

Prompt notification of any accidents in manufacturing or processing of blood reported to: Blood bank director, Armed services blood program director, and FDA.

Title 21

Food and Drugs

Code of Federal Regulations

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.

Chapter 1 (200-299 & 600-799)

cGMP

AABB Inspection Report Form

for Blood banks and transfusion services

Report

Should include: mislabeling, mistyping, shipping/receipt of improper labeled units, test interpretation errors, repeated reactive units, units received that were temporarily or permanently deferred.

200 Series

Drugs

Food and Drug Administration

Enforces regulations to endure safety and efficacy of biologics and drugs and devices that include blood/components and diagnostic reagents used or manufactured.

cGMP

Sets specific QC requirements and covers several aspects of blood bank/ transfusion services

Fatalities

resulting from blood transfusions must be verbally reported to the Director of the Office of Comliance in the Center for Biologics Evaluation and Research within 24 hours. A written report must be submitted within 7 days.