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1237108

Regional Women's Health Group, LLC — FEI 3004088908

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 29, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Marlton, NJ (United States)

Facility

Other inspections at this facility

  • 1168808 (NAI Fri Apr 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096100 (VAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904835 (VAI Wed Nov 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840142 (VAI Thu Jul 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712347 (NAI Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1228621 CFR 1271.80(b)Specimen collections not timely
1249221 CFR 1271.85(a)Infection with communicable disease agents