FDA Inspection 852457 — American National Red Cross (The), Lewis and Clark Region

American National Red Cross (The), Lewis and Clark Region — FEI 3001451955

The FDA completed an inspection of American National Red Cross (The), Lewis and Clark Region on September 20, 2013 in Murray, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 20, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Murray, UT (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
6121 CFR 606.60(a)Provide proper equipment to meet requirements
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations