Form 483

Vitalant Form 483, 2019-07-24

FDA issued a Form 483 to Vitalant on 2019-07-24 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Vitalant · Scottsdale, United States · Issued July 24, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

24 Jul 2019
21 CFR 606.160(e)(1)

Donor deferral record - each location

Cited by Marc A Jackson, Kip J Hanks, Bryce A May

Inspected site

VVitalantScottsdale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(e)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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