Atlas

Form 483

SALUDA MEDICAL PTY. LTD. Form 483, 2022-08-25

FDA issued a Form 483 to SALUDA MEDICAL PTY. LTD. on 2022-08-25 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

SALUDA MEDICAL PTY. LTD. · Macquarie Park, Australia · Issued August 25, 2022

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Aug 2022
21 CFR 820.72(a)

Calibration, Inspection, etc. Procedures Lack of or Inadequ

Cited by Christopher S Genther

Inspected site

SMSALUDA MEDICAL PTY. LTD.Macquarie Park, Australia

Inspection team

CSChristopher S Genther

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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