FDA-Inspected Site

Carter BloodCare - Tyler

10 FDA inspections are on record for Carter BloodCare - Tyler in Tyler, United States.

Clean· No action indicated

Tyler, United States · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-07.

At a glance

Inspections

10

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Mar 2025 – 7 Mar 2025BiologicsClean
10 Jun 2022 – 16 Jun 2022BiologicsClean
30 Jan 2018 – 2 Feb 2018BiologicsClean
25 May 2016 – 1 Jun 2016Biologics483View 483 →
5 Jun 2014 – 6 Jun 2014BiologicsClean
20 Jan 2012Not recorded483On file
20 Oct 2009Not recorded483View 483 →
11 Sep 2008Not recordedClean
7 Sep 2005Not recordedClean
26 Jul 2002Not recordedClean

Observations on record

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

1 Jun 2016
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Elmina E Akwo

1 Jun 2016
21 CFR 606.170(a)

Adverse reaction - Maintenance of Reports

Cited by Elmina E Akwo

1 Jun 2016
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Elmina E Akwo

1 Jun 2016
21 CFR 606.170(a)

Adverse reaction - Maintenance of Repo

Cited by Elmina E Akwo

20 Oct 2009
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Iris C Macinnes

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 606.170(a)Cited across public-safe Form 483 observations2x
21 CFR 606.60(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Carter BloodCare - Tyler's 3 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