Atlas

Form 483

Kraff, Colman R., M.D. Form 483, 2017-06-29

FDA issued a Form 483 to Kraff, Colman R., M.D. on 2017-06-29 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Kraff, Colman R., M.D. · Chicago, United States · Issued June 29, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

29 Jun 2017
21 CFR 812.110(b)

Investigator non-compliance with agreement/plan/regulations

Cited by Shalonda C Clifford

29 Jun 2017
21 CFR 812.140(a)(3)

Investigator's subject records inadequate

Cited by Shalonda C Clifford

Inspected site

KCKraff, Colman R., M.D.Chicago, United States

Inspection team

SCShalonda C Clifford

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.110(b)Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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