Atlas

Form 483

Thomas K. Jones, MD -- Clinical Investigator Form 483, 2011-01-18

FDA issued a Form 483 to Thomas K. Jones, MD -- Clinical Investigator on 2011-01-18 with 4 public-safe observations.

483· Form 483 issued4 observations

Thomas K. Jones, MD -- Clinical Investigator · Seattle, United States · Issued January 18, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

18 Jan 2011
21 CFR 812.100

Investigator non-compliance with agreement/plan/regulations

Cited by Bryce E Mansfield, Graham N Giesen

18 Jan 2011
21 CFR 812.140(a)(2)(i)

Investigator device accountability inadequate

Cited by Bryce E Mansfield, Graham N Giesen

18 Jan 2011
21 CFR 812.150(a)(4)

No approval for investigator change in non-emergency

Cited by Bryce E Mansfield, Graham N Giesen

18 Jan 2011
21 CFR 812.150(a)(7)

Investigator report in response to a request

Cited by Bryce E Mansfield, Graham N Giesen

Inspected site

TKThomas K. Jones, MD -- Clinical InvestigatorSeattle, United States

Inspection team

BEBryce E Mansfield
GNGraham N Giesen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.100Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 812.150(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 812.150(a)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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