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819387

Newport Beach IVF, LLC dba Ovation Fertility — FEI 3003942657

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 26, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Newport Beach, CA (United States)

Facility

Other inspections at this facility

  • 1225580 (NAI Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102784 (NAI Thu Jul 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985378 (NAI Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 696941 (NAI Fri Oct 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1229021 CFR 1271.80(d)(1)Reactive tests--not determined ineligible