Montefiore's Institute for Reproductive Medicine and Health, Hartsdale, NY – FDA Inspections

Inspection records and compliance data for Montefiore's Institute for Reproductive Medicine and Health in Hartsdale, New York. 8 FDA inspections on record, 1 Form 483, last inspected June 24, 2026.

Company Profile

This profile covers Montefiore's Institute for Reproductive Medicine and Health based in Hartsdale, New York, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 2
NAI: 5
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected August 10, 2011. Last inspected June 24, 2026.

Most cited issue areas

Procedures for all other requirements2 inspections
Donors with risks not determined ineligible1 inspection
Prominently labeled (limited use)1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
June 24, 2026	Not classified	Biologics	1327662
August 16, 2023	NAI	Biologics · Blood and Blood Products	1215614
August 16, 2021	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1148967
May 3, 2019	NAI	Biologics · Blood and Blood Products	1088610
March 22, 2017	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1008038
August 10, 2015	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	938861
September 6, 2013	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	847232
August 10, 2011	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	737471

FDA documents

Form 483s (2)

People (1)

Anthony N. Onianwa

Person

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