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1091933

IVFMD - Advanced Reproductive Laboratory — FEI 3004453319

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 4, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Irving, TX (United States)

Facility

Other inspections at this facility

  • 1279855 (NAI Mon Aug 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1163350 (NAI Wed Feb 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937295 (VAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 932643 (NAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 765576 (VAI Wed Feb 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1224221 CFR 1271.55(c)Name and personal info on accompanying records
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV