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793595

Terrebonne General Health System — FEI 2370425

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 6, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Houma, LA (United States)

Facility

Other inspections at this facility

  • 1283764 (NAI Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1217492 (NAI Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102308 (NAI Wed Aug 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000028 (VAI Fri Feb 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928625 (VAI Tue Jun 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
927021 CFR 610.40(h)(2)(ii)Labeling of reactive units, units from deferred donors
9821 CFR 606.100(c)Thorough investigations