Atlas

Form 483

Virbac Corporation Form 483, 2010-11-03

FDA issued a Form 483 to Virbac Corporation on 2010-11-03 with 3 public-safe observations.

483· Form 483 issued3 observations

Virbac Corporation · Bridgeton, United States · Issued November 3, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

3 Nov 2010
21 CFR 211.25(c)

Inadequate number of personnel

Cited by Shafiq Ahadi, Steven D Kehoe

3 Nov 2010
21 CFR 211.84(e)

Rejecting When Specifications Not Met

Cited by Shafiq Ahadi, Steven D Kehoe

3 Nov 2010
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Shafiq Ahadi, Steven D Kehoe

Inspected site

VCVirbac CorporationBridgeton, United States

Inspection team

SAShafiq Ahadi
SDSteven D Kehoe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.25(c)Cited across public-safe Form 483 observations1x
21 CFR 211.84(e)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