Atlas

Form 483

Northwest Comm Hospital IRB Form 483, 2009-02-18

FDA issued a Form 483 to Northwest Comm Hospital IRB on 2009-02-18 with 3 public-safe observations.

483· Form 483 issued3 observations

Northwest Comm Hospital IRB · Arlington Heights, United States · Issued February 18, 2009

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.

18 Feb 2009
21 CFR 50.25(a)(7)

Whom to contact

Cited by Lisa Hayka

18 Feb 2009
21 CFR 56.108(c)

Members present for review

Cited by Lisa Hayka

18 Feb 2009
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Lisa Hayka

Inspected site

NCNorthwest Comm Hospital IRBArlington Heights, United States

Inspection team

LHLisa Hayka

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)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