FDA-Inspected Site

Fertility Unlimited Inc.

7 FDA inspections are on record for Fertility Unlimited Inc. in Akron, United States.

Clean· No action indicated

Akron, United States · Last updated July 9, 2026

Overview

  • 7 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-02.

At a glance

Inspections

7

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Jun 2026BiologicsClean
11 Apr 2023BiologicsClean
4 Dec 2019BiologicsClean
4 Oct 2017BiologicsClean
10 Dec 2015 – 11 Dec 2015BiologicsClean
5 Dec 2013 – 6 Dec 2013BiologicsClean
28 Dec 2011Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

28 Dec 2011
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Nancy L Neiger

28 Dec 2011
21 CFR 1271.80(c)

Kits not FDA approved, specifically labeled

Cited by Nancy L Neiger

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Fertility Unlimited Inc.'s 1 Form 483

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat