Atlas

FDA-Inspected Site

Allendale IRB

4 FDA inspections are on record for Allendale IRB in Old Lyme, United States.

Clean· No action indicated

Old Lyme, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-03-19.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2020 – 19 Mar 2020Medical Devices & Rad HealthClean
14 Sep 2015 – 24 Sep 2015Biologics483View 483 →
23 Feb 2011Not recorded483View 483 →
7 Jun 2001Not recordedClean

Observations on record

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

24 Sep 2015
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Anthony N Onianwa, Anthony W Thomas

24 Sep 2015
21 CFR 56.110(c)

Method to keep members advised

Cited by Anthony N Onianwa, Anthony W Thomas

24 Sep 2015
21 CFR 56.115(a)(3)

Records of continuing review

Cited by Anthony N Onianwa, Anthony W Thomas

24 Sep 2015
21 CFR 56.115(a)(4)

Copies of IRB/CI correspondence

Cited by Anthony N Onianwa, Anthony W Thomas

23 Feb 2011
21 CFR 56.109(f)

Continuing review

Cited by John S Hartford

Investigators

FDA investigators tied to this site in the record.

John L Zaccone1 insp.
Anthony N Onianwa1 insp.
Anthony W Thomas1 insp.
John S Hartford1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 56.110(c)Cited across public-safe Form 483 observations2x
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 56.109(f)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 812.66Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Allendale IRB'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