Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
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
Inspected site
SISugih Instrumendo Abadi, PT.Padalarang, Jawa Barat, Indonesia
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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