Home / Inspections / 1192782

1192782

Cooper Institute for Advanced Reproductive Medicine — FEI 3011006339

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 9, 2022
Fiscal Year
2023
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Houston, TX (United States)

Facility

Other inspections at this facility

  • 1223634 (OAI Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146456 (OAI Mon Jul 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017306 (NAI Wed Apr 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907753 (VAI Mon Dec 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1225021 CFR 1271.55(d)(4)Ten year retention
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1249221 CFR 1271.85(a)Infection with communicable disease agents
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV