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920484

V A Medical Center Erie — FEI 2571109

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Erie, PA (United States)

Facility

Other inspections at this facility

  • 1252937 (NAI Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094024 (NAI Wed Jun 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014332 (VAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804856 (NAI Mon Oct 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695398 (NAI Tue Oct 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration