Atlas

Form 483

St Joseph Mercy Health System IRB Form 483, 2011-03-18

FDA issued a Form 483 to St Joseph Mercy Health System IRB on 2011-03-18 with 1 public-safe observation.

483· Form 483 issued1 observation

St Joseph Mercy Health System IRB · Ypsilanti, United States · Issued March 18, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

18 Mar 2011
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by L'Oreal F Walker

Inspected site

SJSt Joseph Mercy Health System IRBYpsilanti, United States

Inspection team

LFL'Oreal F Walker

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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