FDA-Inspected Site

Donor Alliance, Inc.

7 FDA inspections are on record for Donor Alliance, Inc. in Denver, United States.

483· Form 483 issued

Denver, United States · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-15.

At a glance

Inspections

7

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Jan 2026 – 15 Jan 2026Biologics483View 483 →
22 Jun 2022 – 28 Jun 2022BiologicsClean
22 Jun 2022BiologicsClean
11 May 2017 – 24 May 2017BiologicsClean
12 Nov 2013 – 14 Nov 2013BiologicsClean
17 Nov 2011Not recordedClean
4 Mar 2010Not recorded483View 483 →

Observations on record

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

15 Jan 2026
21 CFR 1271.160(b)(4)

Training of personnel

Cited by Shelley H Beausoleil, Eric Zhu, Conor J Mccarron, Deepa E Vadakkan

15 Jan 2026
21 CFR 1271.210(a)

Use prior to verification

Cited by Shelley H Beausoleil, Eric Zhu, Conor J Mccarron, Deepa E Vadakkan

15 Jan 2026
21 CFR 1271.350(a)(1)

Investigation of adverse reactions

Cited by Shelley H Beausoleil, Eric Zhu, Conor J Mccarron, Deepa E Vadakkan

15 Jan 2026
21 CFR 1271.47(a)

Design of procedures to ensure compliance

Cited by Shelley H Beausoleil, Eric Zhu, Conor J Mccarron, Deepa E Vadakkan

15 Jan 2026
21 CFR 1271.47(e)

Adopting procedures from another organization

Cited by Shelley H Beausoleil, Eric Zhu, Conor J Mccarron, Deepa E Vadakkan

Investigators

FDA investigators tied to this site in the record.

Eric Zhu1 insp.
Deepa E Vadakkan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.160(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 1271.180(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.210(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.270(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.270(e)Cited across public-safe Form 483 observations1x
21 CFR 1271.350(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.47(e)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Donor Alliance, Inc.'s 2 Form 483s

Source PDFs, 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