Home / Inspections / 1026748

1026748

Overlake Reproductive Health Laboratory LLC — FEI 3004174071

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 27, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bellevue, WA (United States)

Facility

Other inspections at this facility

  • 1200992 (NAI Thu Mar 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967310 (VAI Tue Apr 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905615 (VAI Tue Dec 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862534 (VAI Fri Jan 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 706568 (NAI Wed Jan 05 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1224021 CFR 1271.55(b)(3)Name and address on summary
1224221 CFR 1271.55(c)Name and personal info on accompanying records
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled
1249321 CFR 1271.90(c)Eligibility not required--warning labels