Atlas

FDA-Inspected Site

Sugih Instrumendo Abadi, PT.

5 FDA inspections are on record for Sugih Instrumendo Abadi, PT. in Padalarang, Jawa Barat, Indonesia.

483· Form 483 issued

Padalarang, Jawa Barat, Indonesia · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-12.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Mar 2026 – 12 Mar 2026Medical Devices & Rad Health483View 483 →
30 Oct 2023 – 2 Nov 2023Medical Devices & Rad Health483View 483 →
28 Jun 2012Not recordedWLOn file
14 May 2009Not recordedClean
3 Jun 2004Not recordedClean

Observations on record

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

12 Mar 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Tiki Dixon

12 Mar 2026
ISO 13485:2016 Clause 7.3.9

Procedures to control design and development changes not documented

Cited by Tiki Dixon

12 Mar 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Tiki Dixon

12 Mar 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by Tiki Dixon

2 Nov 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dawn M Braswell

Investigators

FDA investigators tied to this site in the record.

Tiki Dixon1 insp.
Dawn M Braswell1 insp.
Thai T Duong1 insp.
Richard J Tucker1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.9Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sugih Instrumendo Abadi, PT.'s 3 Form 483s

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