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774638

Mennonite General Hospital, Inc. — FEI 2675246

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Aibonito, PR (United States)

Facility

Other inspections at this facility

  • 1291586 (NAI Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210198 (NAI Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114056 (NAI Tue Nov 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055332 (NAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967723 (NAI Tue Jan 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15921 CFR 606.160(a)(1)Legibility and indelibility
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8821 CFR 606.100(b)(9)Written methods for investigating adverse reactions