Fresenius Kabi Horatev CZ S.R.O. FDA Record
- Latest inspection NAI · Jul 25, 2025
- No warning letters matched by name
Fresenius Kabi Horatev CZ S.R.O. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fresenius Kabi Horatev CZ S.R.O." is on file.
- Latest inspection
- Jul 25, 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 |
|---|---|---|---|---|
| Jul 25, 2025 | Horatev, Czech Republic | Biologics | No Action Indicated (NAI) | 3013246506 |
- 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 3013246506 | Horatev, Czech Republic | 1 | Jul 25, 2025 |
Fresenius Kabi Horatev CZ S.R.O. and the FDA: common questions
Has Fresenius Kabi Horatev CZ S.R.O. received an FDA warning letter?
No FDA warning letter addressed to the name "Fresenius Kabi Horatev CZ S.R.O." 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 Fresenius Kabi Horatev CZ S.R.O. received an FDA Form 483?
FDA has not published a Form 483 for "Fresenius Kabi Horatev CZ S.R.O." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Fresenius Kabi Horatev CZ S.R.O.?
The most recent FDA inspection on file ended Jul 25, 2025 at Horatev, Czech Republic and was classified NAI. FDA has 1 inspection of Fresenius Kabi Horatev CZ S.R.O. on file.
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