Sugih Instrumendo Abadi, PT. FDA Record
- Latest inspection NAI · May 14, 2009
- Last warning letter 2012
Sugih Instrumendo Abadi, PT. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sugih Instrumendo Abadi, PT., the most recent on Oct 22, 2012.
- Latest inspection
- May 14, 2009 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Sugih Instrumendo Abadi, PT. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Oct 22, 2012 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 14, 2009 | Padalarang, Jawa Barat, Indonesia | Devices | No Action Indicated (NAI) | 3002118752 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Sugih Instrumendo Abadi, PT.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002118752 | Padalarang, Jawa Barat, Indonesia | 1 | May 14, 2009 |
Sugih Instrumendo Abadi, PT. and the FDA: common questions
Has Sugih Instrumendo Abadi, PT. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Sugih Instrumendo Abadi, PT.. The most recent is dated Oct 22, 2012.
Has Sugih Instrumendo Abadi, PT. received an FDA Form 483?
FDA has not published a Form 483 for "Sugih Instrumendo Abadi, PT." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sugih Instrumendo Abadi, PT.?
The most recent FDA inspection on file ended May 14, 2009 at Padalarang, Jawa Barat, Indonesia and was classified NAI. FDA has 1 inspection of Sugih Instrumendo Abadi, PT. on file.
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