Atlas

Form 483

University of Massachusetts Chan Medical School IRB Form 483, 2010-09-22

FDA issued a Form 483 to University of Massachusetts Chan Medical School IRB on 2010-09-22 with 3 public-safe observations.

483· Form 483 issued3 observations

University of Massachusetts Chan Medical School IRB · Worcester, United States · Issued September 22, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

UOUniversity of Massachusetts Chan Medical School IRBWorcester, United States

Inspection team

MMMichelle M Noe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.110(c)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere