Arc Medical Supplies (Beijing) Co, Ltd. FDA Record
Arc Medical Supplies (Beijing) Co, Ltd. has 0 FDA recalls, 3 inspections, 7 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Arc Medical Supplies (Beijing) Co, Ltd., the most recent on Mar 28, 2011.
- Latest inspection
- Jun 18, 2025 · NAI
- Latest 510(k)
- Oct 9, 2002
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | 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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Arc Medical Supplies (Beijing) Co, Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 28, 2011 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 18, 2025 | Beijing, China | Devices | No Action Indicated (NAI) | 3003267729 |
| Jan 29, 2015 | Beijing, China | Devices | No Action Indicated (NAI) | 3003267729 |
| Dec 14, 2010 | Beijing, China | Devices | Official Action Indicated (OAI) | 3003267729 |
- 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 Arc Medical Supplies (Beijing) Co, Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003267729 | Beijing, China | 3 | Jun 18, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. | Oct 9, 2002 |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | Sep 10, 2002 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Apr 28, 2000 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Apr 28, 2000 |
| K000540 | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP | Apr 27, 2000 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Apr 27, 2000 |
| K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP | Apr 27, 2000 |
Arc Medical Supplies (Beijing) Co, Ltd. and the FDA: common questions
Has Arc Medical Supplies (Beijing) Co, Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Arc Medical Supplies (Beijing) Co, Ltd.. The most recent is dated Mar 28, 2011.
Has Arc Medical Supplies (Beijing) Co, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Arc Medical Supplies (Beijing) Co, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Arc Medical Supplies (Beijing) Co, Ltd.?
The most recent FDA inspection on file ended Jun 18, 2025 at Beijing, China and was classified NAI. FDA has 3 inspections of Arc Medical Supplies (Beijing) Co, Ltd. on file, 1 of them classified OAI (official action indicated).
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