SESMED (Cambodia) Healthcare Product Co., Ltd. FDA Record
- Latest inspection NAI · Mar 13, 2025
- No warning letters matched by name
SESMED (Cambodia) Healthcare Product Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SESMED (Cambodia) Healthcare Product Co., Ltd." is on file.
- Latest inspection
- Mar 13, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Mar 13, 2025 | Sihanoukville, Cambodia | Devices | No Action Indicated (NAI) | 3013548473 |
- 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 3013548473 | Sihanoukville, Cambodia | 1 | Mar 13, 2025 |
SESMED (Cambodia) Healthcare Product Co., Ltd. and the FDA: common questions
Has SESMED (Cambodia) Healthcare Product Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "SESMED (Cambodia) Healthcare Product Co., Ltd." 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 SESMED (Cambodia) Healthcare Product Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "SESMED (Cambodia) Healthcare Product Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SESMED (Cambodia) Healthcare Product Co., Ltd.?
The most recent FDA inspection on file ended Mar 13, 2025 at Sihanoukville, Cambodia and was classified NAI. FDA has 1 inspection of SESMED (Cambodia) Healthcare Product Co., Ltd. on file.
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