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FDA Inspection 967913 — UF Health Shands Medical Laboratories Blood Bank

UF Health Shands Medical Laboratories Blood Bank — FEI 1073823

The FDA completed an inspection of UF Health Shands Medical Laboratories Blood Bank on February 25, 2016 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 25, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Gainesville, FL (United States)

Citations

IDCFRDescription
922521 CFR 606.171Biological product deviation report

Facility

Other inspections at this facility

  • 1280793 (NAI Mon Aug 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202804 (NAI Wed Apr 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039044 (VAI Thu Jan 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888207 (NAI Wed Jul 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798187 (NAI Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources