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895464

Manhattan Reproductive Medicine, PC — FEI 3004753417

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 18, 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

  • 1240497 (NAI Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173216 (NAI Wed Jun 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117589 (VAI Wed Feb 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842598 (OAI Wed Jul 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 635463 (VAI Thu Jan 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
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
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled