FDA-Inspected Site

Vitalant

10 FDA inspections are on record for Vitalant in Lakewood, United States.

483· Form 483 issued

Lakewood, United States · Last updated August 15, 2026

Overview

  • 10 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-02.

At a glance

Inspections

10

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 Feb 2026 – 2 Mar 2026Biologics483View 483 →
7 Dec 2022BiologicsClean
23 Oct 2018BiologicsClean
8 Dec 2016BiologicsClean
10 Feb 2015BiologicsClean
3 Dec 2013BiologicsClean
2 Feb 2012Not recordedClean
3 May 2010Not recorded483View 483 →
11 Dec 2008Not recordedClean
22 Apr 2002Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

2 Mar 2026
21 CFR 606.100(c)

Thorough investigations

Cited by Conor J Mccarron

2 Mar 2026
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Conor J Mccarron

2 Mar 2026
21 CFR 640.4(e)

Donor identification

Cited by Conor J Mccarron

3 May 2010
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Randy V Bong

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

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 606.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 640.4(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Vitalant's 2 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat