Atlas

FDA-Inspected Site

ITI Manufacturing, Inc.

3 FDA inspections are on record for ITI Manufacturing, Inc. in Sugar Land, United States.

483· Form 483 issued

Sugar Land, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-03.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jun 2026 – 3 Jun 2026Medical Devices & Rad Health483View 483 →
18 Oct 2022 – 28 Oct 2022Medical Devices & Rad Health483View 483 →
18 Oct 2022 – 21 Oct 2022Medical Devices & Rad HealthClean

Observations on record

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

3 Jun 2026
ISO 13485:2016 Clause 4.1.5

External party controls do not include written quality agreements

Cited by Yuliana Hernandez-Magana

3 Jun 2026
ISO 13485:2016 Clause 8.2.4

Internal audit procedures not documented

Cited by Yuliana Hernandez-Magana

3 Jun 2026
ISO 13485:2016 Clause 8.3.1

Records of nonconforming product and actions taken not maintained

Cited by Yuliana Hernandez-Magana

28 Oct 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Ellen J Tave

28 Oct 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Ellen J Tave

Investigators

FDA investigators tied to this site in the record.

Ellen J Tave2 insp.
Yuliana Hernandez-Magana1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations4x
21 CFR 820.140Cited across public-safe Form 483 observations4x
ISO 13485:2016 Clause 4.1.5Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ITI Manufacturing, Inc.'s 2 Form 483s

Source PDFs 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