Atlas

Form 483

University Of Virginia Health System Form 483, 2012-03-15

FDA issued a Form 483 to University Of Virginia Health System on 2012-03-15 with 3 public-safe observations.

483· Form 483 issued3 observations

University Of Virginia Health System · Charlottesville, United States · Issued March 15, 2012

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.

15 Mar 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Carrie L Doupnik

15 Mar 2012
21 CFR 606.100(c)

Thorough investigations

Cited by Carrie L Doupnik

15 Mar 2012
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Carrie L Doupnik

Inspected site

UOUniversity Of Virginia Health SystemCharlottesville, United States

Inspection team

CLCarrie L Doupnik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)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