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FDA Inspection 1058813 — The American National Red Cross Diagnostic Manufacturing Division

The American National Red Cross Diagnostic Manufacturing Division — FEI 1177732

The FDA completed an inspection of The American National Red Cross Diagnostic Manufacturing Division on April 27, 2018 in Gaithersburg, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Gaithersburg, MD (United States)

Facility

Other inspections at this facility

  • 1326648 (NAI Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231137 (NAI Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991584 (NAI Wed Jun 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898271 (VAI Fri Aug 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752096 (VAI Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources