Atlas

FDA-Inspected Site

University of Massachusetts Chan Medical School IRB

5 FDA inspections are on record for University of Massachusetts Chan Medical School IRB in Worcester, United States.

Clean· No action indicated

Worcester, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-11-07.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Nov 2023 – 7 Nov 2023Medical Devices & Rad HealthClean
26 Jan 2016 – 28 Jan 2016Medical Devices & Rad HealthClean
22 Sep 2010Not recorded483View 483 →
4 Dec 2009Not recorded483View 483 →
6 Jul 2000Not recordedClean

Observations on record

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

22 Sep 2010
21 CFR 56.110(c)

Method to keep members advised

Cited by Michelle M Noe

22 Sep 2010
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Michelle M Noe

22 Sep 2010
21 CFR 56.115(a)(6)

Written procedures per 56.108(a) and (b)

Cited by Michelle M Noe

4 Dec 2009
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Michelle M Noe, Leo B Zadecky

4 Dec 2009
21 CFR 56.108(a)(1)

Reporting findings and actions to investigator/institution

Cited by Michelle M Noe, Leo B Zadecky

Investigators

FDA investigators tied to this site in the record.

Michelle M Noe2 insp.
Matthew C Watson1 insp.
Asia D Clark1 insp.
Michael P Anthony1 insp.
Leo B Zadecky1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 56.110(c)Cited across public-safe Form 483 observations2x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 56.108(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.108(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(6)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site'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