Atlas

FDA-Inspected Site

Iso-Tex Diagnostics, Inc.

16 FDA inspections are on record for Iso-Tex Diagnostics, Inc. in Alvin, United States.

483· Form 483 issued

Alvin, United States · Last updated July 9, 2026

Overview

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

At a glance

Inspections

16

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Jan 2026 – 3 Feb 2026Human Drugs483View 483 →
30 Jan 2023 – 10 Feb 2023Human DrugsWLView 483 →
29 Jan 2020 – 7 Feb 2020Human DrugsClean
16 Aug 2018 – 29 Aug 2018Human DrugsClean
24 Jan 2018 – 31 Jan 2018Human Drugs483View 483 →
6 Jul 2015 – 10 Jul 2015Human Drugs483View 483 →
27 Aug 2014Human DrugsClean
16 Sep 2013 – 27 Sep 2013Human DrugsClean
7 Sep 2012Not recorded483View 483 →
12 Sep 2011Not recordedWLView 483 →
2 Jun 2010Not recordedWLView 483 →
10 Dec 2008Not recordedClean

Observations on record

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

3 Feb 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Camerson E Moore, Rodney L Tinzie, Oluwasefunm Agbanigo

3 Feb 2026
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Camerson E Moore, Rodney L Tinzie, Oluwasefunm Agbanigo

3 Feb 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Camerson E Moore, Rodney L Tinzie, Oluwasefunm Agbanigo

3 Feb 2026
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Camerson E Moore, Rodney L Tinzie, Oluwasefunm Agbanigo

3 Feb 2026
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Camerson E Moore, Rodney L Tinzie, Oluwasefunm Agbanigo

Investigators

FDA investigators tied to this site in the record.

Stephen D Brown5 insp.
Camerson E Moore2 insp.
Rodney L Tinzie1 insp.
Oluwasefunm Agbanigo1 insp.
Christopher N Tran1 insp.
Lisa R Whitt1 insp.
Andrea A Branche1 insp.
Patty P Kaewussdangkul1 insp.
Carla J Lundi1 insp.
Stacie A Woods1 insp.
Brian J Ryan1 insp.
Mark C Flotte1 insp.
Daniel J Lahar1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations7x
21 CFR 211.68(a)Cited across public-safe Form 483 observations5x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.56(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.105(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.42(a)Cited across public-safe Form 483 observations2x
21 CFR 211.80(b)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Iso-Tex Diagnostics, Inc.'s 7 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