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1179343

Georgia Center for Reproductive Medicine — FEI 3005289937

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 8, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Savannah, GA (United States)

Facility

Other inspections at this facility

  • 1243737 (NAI Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059990 (NAI Tue Jul 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934356 (NAI Thu Jul 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834076 (NAI Fri May 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 631152 (NAI Wed Dec 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV