Royal King Infant Products Co., Ltd. FDA Record
Royal King Infant Products Co., Ltd. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Royal King Infant Products Co., Ltd., the most recent on Jul 26, 2012.
- Latest inspection
- May 3, 2012 · OAI
- Latest 510(k)
- Dec 8, 2003
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | 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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Royal King Infant Products Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jul 26, 2012 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 3, 2012 | Samutsakhon, Thailand | Devices | Official Action Indicated (OAI) | 1000605000 |
- 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 Royal King Infant Products Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000605000 | Samutsakhon, Thailand | 1 | May 3, 2012 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K031094 | FLUID FILLED TEETHERS | Dec 8, 2003 |
Royal King Infant Products Co., Ltd. and the FDA: common questions
Has Royal King Infant Products Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Royal King Infant Products Co., Ltd.. The most recent is dated Jul 26, 2012.
Has Royal King Infant Products Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Royal King Infant Products Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Royal King Infant Products Co., Ltd.?
The most recent FDA inspection on file ended May 3, 2012 at Samutsakhon, Thailand and was classified OAI. FDA has 1 inspection of Royal King Infant Products Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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