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849698

STERIS Laboratories, Inc. — FEI 2183828

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 13, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Brooklyn Park, MN (United States)

Facility

Other inspections at this facility

  • 1277414 (NAI Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028628 (NAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009654 (NAI Wed Apr 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931470 (NAI Tue Jun 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862730 (NAI Wed Jan 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1237221 CFR 1271.200(c)Calibrated per established schedules
1239821 CFR 1271.230(a)Validation & approval--established procedures