Atlas

Form 483

William D Koltun, MD Form 483, 2012-02-24

FDA issued a Form 483 to William D Koltun, MD on 2012-02-24 with 4 public-safe observations.

483· Form 483 issued4 observations

William D Koltun, MD · San Diego, United States · Issued February 24, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

24 Feb 2012
21 CFR 312.60

FD-1572, protocol compliance

Cited by Courtney N Long

24 Feb 2012
21 CFR 312.62(a)

Unused drug disposition (investigator)

Cited by Courtney N Long

24 Feb 2012
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Courtney N Long

24 Feb 2012
21 CFR 312.62(c)

Record retention

Cited by Courtney N Long

Inspected site

WDWilliam D Koltun, MDSan Diego, United States

Inspection team

CNCourtney N Long

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.62(a)Cited across public-safe Form 483 observations1x
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x
21 CFR 312.62(c)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