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774479

Health Park Medical Center — FEI 3003368404

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Fort Myers, FL (United States)

Facility

Other inspections at this facility

  • 1246299 (NAI Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1163017 (VAI Mon Feb 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036267 (NAI Thu Nov 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965270 (NAI Thu Feb 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875355 (NAI Tue Apr 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
11721 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
4921 CFR 606.40(a)(9)Provide space for all packaging, labeling, & finishing ops.
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
907721 CFR 600.12(a)Maintenance - completeness