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718273

Alabama Organ Center - Mobile Region — FEI 3006165039

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 24, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Mobile, AL (United States)

Facility

Other inspections at this facility

  • 1072991 (NAI Thu Nov 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993865 (NAI Fri Oct 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905871 (NAI Fri Dec 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820837 (VAI Tue Mar 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1232621 CFR 1271.160(c)Quality audits performed periodically
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234221 CFR 1271.190(a)Size, construction, location--prevent mix-ups etc.
1235121 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
1235421 CFR 1271.190(d)(2)Documentation of activities
1236921 CFR 1271.200(b)Procedures inadequate
1241121 CFR 1271.260(a)Contamination, mix ups, improper release
1502021 CFR 1271.200(e)Documentation of maintenance and cleaning