Prince Medical, Inc. FDA Record
- Latest inspection OAI · Mar 28, 2012
- Last warning letter 2012
Prince Medical, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Prince Medical, Inc., the most recent on Aug 6, 2012. FDA has published 1 Form 483 for Prince Medical, Inc..
- Latest inspection
- Mar 28, 2012 · OAI
- Latest 510(k)
- Aug 10, 1998
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 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Prince Medical, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 6, 2012 · Record page |
Prince Medical, Inc. Form 483s
| Date | Document | FEI |
|---|---|---|
| Dec 8, 2022 · Document on fda.gov | 483 | 3000296634 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 28, 2012 | Ercuis, France | Devices | Official Action Indicated (OAI) | 3000296634 |
- 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 Prince Medical, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3000296634 | Ercuis, France | 1 | Mar 28, 2012 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K981855 | PRINCE MEDICAL CEMENT PLUG | Aug 10, 1998 |
Prince Medical, Inc. and the FDA: common questions
Has Prince Medical, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Prince Medical, Inc.. The most recent is dated Aug 6, 2012.
Has Prince Medical, Inc. received an FDA Form 483?
FDA has published 1 Form 483 for Prince Medical, Inc. in its reading room, the most recent dated Dec 8, 2022. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Prince Medical, Inc.?
The most recent FDA inspection on file ended Mar 28, 2012 at Ercuis, France and was classified OAI. FDA has 1 inspection of Prince Medical, Inc. on file, 1 of them classified OAI (official action indicated).
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