Form 483

Versiti Illinois Inc Form 483, 2010-01-14

FDA issued a Form 483 to Versiti Illinois Inc on 2010-01-14 with 2 public-safe observations.

483· Form 483 issued2 observations

Versiti Illinois Inc · Aurora, United States · Issued January 14, 2010

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.

14 Jan 2010
21 CFR 606.100(b)(19)

Notification of consignees re: antibody test results

Cited by Lequita M Mayhew

14 Jan 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Lequita M Mayhew

Inspected site

VIVersiti Illinois IncAurora, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)(19)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)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