Fertility Unlimited Inc., Akron, OH – FDA Inspections

Inspection records and compliance data for Fertility Unlimited Inc. in Akron, Ohio. 7 FDA inspections on record, last inspected June 02, 2026.

Company Profile

This profile covers Fertility Unlimited Inc. based in Akron, Ohio, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 1
NAI: 6
Form 483s: 0
Warning letters: 0

First inspected December 28, 2011. Last inspected June 2, 2026.

Most cited issue areas

Kits not FDA approved, specifically labeled1 inspection
Risk factors, clinical evidence1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
June 2, 2026	NAI	· Human Cellular, Tissue, and Gene Therapies	1321382
April 11, 2023	NAI	Biologics · Blood and Blood Products	1203012
December 4, 2019	NAI	Biologics · Blood and Blood Products	1112668
October 4, 2017	NAI	Biologics · Blood and Blood Products	1029232
December 11, 2015	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	952991
December 6, 2013	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	857947
December 28, 2011	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	759778

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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