Atlas

Form 483

Uscom Limited Form 483, 2022-09-01

FDA issued a Form 483 to Uscom Limited on 2022-09-01 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Uscom Limited · Sydney, Australia · Issued September 1, 2022

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.

1 Sep 2022
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Christopher S Genther

1 Sep 2022
21 CFR 820.200(a)

Servicing - Lack of or inadequate procedures

Cited by Christopher S Genther

1 Sep 2022
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Christopher S Genther

Inspected site

ULUscom LimitedSydney, Australia

Inspection team

CSChristopher S Genther

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.200(a)Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited 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