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Form 483

Aus Systems Pty Ltd Form 483, 2026-06-25

FDA issued a Form 483 to Aus Systems Pty Ltd on 2026-06-25 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Aus Systems Pty Ltd · Allenby Gardens, Australia · Issued June 25, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

25 Jun 2026
21 CFR 803.17

Lack of Written MDR Procedures

Cited by John A Sciacchitano

25 Jun 2026
ISO 13485:2016 Clause 7.5.6

Records of validation of processes and necessary actions not maintained

Cited by John A Sciacchitano

Inspected site

ASAus Systems Pty LtdAllenby Gardens, Australia

Inspection team

JAJohn A Sciacchitano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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