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730322

Roswell Park Cancer Institute Corporation. Div. of Pathology — FEI 1372120

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Buffalo, NY (United States)

Facility

Other inspections at this facility

  • 1284298 (NAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200624 (NAI Mon Mar 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084076 (NAI Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998259 (NAI Fri Jan 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908088 (NAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test
441321 CFR 211.194(a)(8)Second person sign off
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs