Atlas

Form 483

ITI Manufacturing, Inc. Form 483, 2026-06-03

FDA issued a Form 483 to ITI Manufacturing, Inc. on 2026-06-03 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

ITI Manufacturing, Inc. · Sugar Land, United States · Issued June 3, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

IMITI Manufacturing, Inc.Sugar Land, United States

Inspection team

YHYuliana Hernandez-Magana

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere