FDA Inspection
Sugih Instrumendo Abadi, PT.Sugih Instrumendo Abadi, PT. – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns Sugih Instrumendo Abadi, PT., with an inspection on March 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Sugih Instrumendo Abadi, PT.
- Inspection Date
- March 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · d9931f82-1ffd-4dc8-87fe-36d6d7511ff2
Inspection Facts
- Inspection number
- 1307998
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Sugih Instrumendo Abadi, PT.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| May 14, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sugih Instrumendo Abadi, PT.
- FDA Inspection 1222583 - 2023-11-02
- FDA Inspection 586556 - 2009-05-14
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