Atlas

Form 483

Vitalant Form 483, 2015-02-06

FDA issued a Form 483 to Vitalant on 2015-02-06 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Vitalant · Scottsdale, United States · Issued February 6, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

6 Feb 2015
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Tania Y Hall, Robert D Tollefsen, Phillip M Pontikos

6 Feb 2015
21 CFR 606.100(c)

Thorough investigations

Cited by Tania Y Hall, Robert D Tollefsen, Phillip M Pontikos

Inspected site

VVitalantScottsdale, United States

Inspection team

TYTania Y Hall
RDRobert D Tollefsen
PMPhillip M Pontikos

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(a)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