Home / Inspections / 878293

878293

Gramercy Fertility Services — FEI 3007343484

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 8, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1021259 (NAI Wed Jun 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989742 (NAI Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 788892 (NAI Fri Jun 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772372 (OAI Thu Mar 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 726027 (OAI Wed May 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1222921 CFR 1271.50(a)Determination based on screening and testing
1223021 CFR 1271.50(a)Responsible person to determine, document
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1227821 CFR 1271.75(a)(2)Risks associated with xenotransplantation
1249021 CFR 1271.85(b)(1)Cell-associated CD