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.