Atlas

Form 483

Lowe, John E., MD Form 483, 2011-02-15

FDA issued a Form 483 to Lowe, John E., MD on 2011-02-15 with 2 public-safe observations.

483· Form 483 issued2 observations

Lowe, John E., MD · Ogden, United States · Issued February 15, 2011

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.

15 Feb 2011
21 CFR 312.60

FD-1572, protocol compliance

Cited by Christine I Shaw

15 Feb 2011
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Christine I Shaw

Inspected site

LJLowe, John E., MDOgden, United States

Inspection team

CIChristine I Shaw

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(b)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