FDA-Inspected Site

Illume Fertility

8 FDA inspections are on record for Illume Fertility in Norwalk, United States.

483· Form 483 issued

Norwalk, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-08.

At a glance

Inspections

8

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 May 2026 – 8 May 2026Biologics483View 483 →
28 Jun 2023 – 30 Jun 2023BiologicsClean
18 Feb 2021 – 23 Feb 2021BiologicsClean
28 Mar 2018 – 3 Apr 2018BiologicsClean
28 Mar 2016 – 6 Apr 2016Biologics483View 483 →
11 Dec 2013 – 13 Dec 2013BiologicsClean
5 Mar 2012Not recordedClean
2 Dec 2009Not recordedClean

Observations on record

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

8 May 2026
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Irina Gaberman, Chanel E Crawford

8 May 2026
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Irina Gaberman, Chanel E Crawford

6 Apr 2016
21 CFR 1271.47(a)

Procedures for all steps

Cited by Anthony N Onianwa

6 Apr 2016
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Anthony N Onianwa

6 Apr 2016
21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Anthony N Onianwa

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 1271.47(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Illume Fertility's 2 Form 483s

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