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820698

Olympia Women's Health — FEI 3003973137

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 1, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Olympia, WA (United States)

Facility

Other inspections at this facility

  • 1190768 (NAI Thu Oct 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027846 (NAI Wed Sep 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979044 (VAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907429 (VAI Tue Dec 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854710 (VAI Tue Oct 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1223021 CFR 1271.50(a)Responsible person to determine, document
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled
1229021 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
1249221 CFR 1271.85(a)Infection with communicable disease agents
1249321 CFR 1271.90(c)Eligibility not required--warning labels