Contract Medical International Spol. Sr.O. FDA Record
- Latest inspection VAI · Nov 9, 2022
- Last warning letter 2012
Contract Medical International Spol. Sr.O. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Contract Medical International Spol. Sr.O., the most recent on Dec 12, 2012.
- Latest recall
- Z-2532-2025 · Jul 30, 2025 · filed under Contract Medical International
- Latest inspection
- Nov 9, 2022 · VAI
Newer recall under related name Contract Medical International: Jul 30, 2025, Z-2532-2025.
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 | 3 | 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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Contract Medical International Spol. Sr.O. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Dec 12, 2012 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 9, 2022 | Hradec Kralove 3, Czech Republic | Devices | Voluntary Action Indicated (VAI) | 3004563801 |
| Jul 2, 2015 | Hradec Kralove 3, Czech Republic | Devices | No Action Indicated (NAI) | 3004563801 |
| Aug 9, 2012 | Hradec Kralove 3, Czech Republic | Devices | Official Action Indicated (OAI) | 3004563801 |
- 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 Contract Medical International Spol. Sr.O.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004563801 | Hradec Kralove 3, Czech Republic | 3 | Nov 9, 2022 |
Contract Medical International Spol. Sr.O. and the FDA: common questions
Has Contract Medical International Spol. Sr.O. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Contract Medical International Spol. Sr.O.. The most recent is dated Dec 12, 2012.
Has Contract Medical International Spol. Sr.O. received an FDA Form 483?
FDA has not published a Form 483 for "Contract Medical International Spol. Sr.O." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Contract Medical International Spol. Sr.O.?
The most recent FDA inspection on file ended Nov 9, 2022 at Hradec Kralove 3, Czech Republic and was classified VAI. FDA has 3 inspections of Contract Medical International Spol. Sr.O. on file, 1 of them classified OAI (official action indicated).
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