Illume Fertility, Norwalk, CT – FDA Inspections

Inspection records and compliance data for Illume Fertility in Norwalk, Connecticut. 8 FDA inspections on record, 1 Form 483, last inspected May 08, 2026.

Company Profile

This profile covers Illume Fertility based in Norwalk, Connecticut, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 1
NAI: 6
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected December 2, 2009. Last inspected May 8, 2026.

Most cited issue areas

Determination based on screening and testing1 inspection
Eligibility not required--warning labels1 inspection
Name and personal info on accompanying records1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
May 8, 2026	Not classified	Biologics · Human Cellular, Tissue, and Gene Therapies	1316476
June 30, 2023	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1209647
February 23, 2021	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1136119
April 3, 2018	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1049283
April 6, 2016	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	964581
December 13, 2013	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	859492
March 5, 2012	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	770643
December 2, 2009	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	631846

FDA documents

Form 483s (1)

Form 483s · May 8, 2026

People (2)

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