Scandinavian Health Limited FDA Record
Scandinavian Health Limited has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Scandinavian Health Limited" is on file.
- Latest inspection
- Feb 19, 2016 · NAI
- Latest 510(k)
- Sep 12, 2014
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 19, 2016 | Taoyuan City, Taiwan | Devices | No Action Indicated (NAI) | 3004483565 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004483565 | Taoyuan City, Taiwan | 1 | Feb 19, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K141384 | WHISPERJECT AUTOINJECTOR | Sep 12, 2014 |
| K124026 | LOBSTER AUTO-INJECTOR | Sep 13, 2013 |
| K120191 | PUSH-ON NEEDLE 30GX8MM | May 23, 2012 |
| K954729 | PEN-INJECT 2.25 | Jan 29, 1996 |
Scandinavian Health Limited and the FDA: common questions
Has Scandinavian Health Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Scandinavian Health Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Scandinavian Health Limited received an FDA Form 483?
FDA has not published a Form 483 for "Scandinavian Health Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Scandinavian Health Limited?
The most recent FDA inspection on file ended Feb 19, 2016 at Taoyuan City, Taiwan and was classified NAI. FDA has 1 inspection of Scandinavian Health Limited on file.
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