Kofinas Fertility Group - Inspection Records

Inspection records and compliance data for Kofinas Fertility Group in New York, New York. 8 FDA inspections on record, 2 Form 483s, last inspected April 09, 2025.

Company Profile

This profile covers Kofinas Fertility Group based in New York, New York, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 4
NAI: 4
Form 483s: 2
Warning letters: 0

First inspected August 19, 2009. Last inspected April 9, 2025.

Most cited issue areas

Accurate, indelible, legible3 inspections
Responsible person to determine, document3 inspections
Determination based on screening and testing2 inspections

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
April 9, 2025	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1266536
July 25, 2023	VAI	Biologics · Blood and Blood Products	1210757
February 13, 2020	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1122513
June 25, 2018	VAI	Biologics · Blood and Blood Products	1056801
March 11, 2016	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	963390
December 4, 2013	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	857553
September 13, 2012	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	798579
August 19, 2009	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	606273

FDA documents

Form 483s (2)

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