ALS Czech Republic, S.R.O. FDA Record
ALS Czech Republic, S.R.O. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ALS Czech Republic, S.R.O." is on file.
- Latest inspection
- Apr 25, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | Prague 9, Czech Republic | Drugs | Voluntary Action Indicated (VAI) | 3006712025 |
| Feb 29, 2024 | Prague 9, Czech Republic | Drugs | Voluntary Action Indicated (VAI) | 3014498434 |
| Jan 20, 2022 | Prague 9, Czech Republic | Drugs | Voluntary Action Indicated (VAI) | 3006712025 |
| May 29, 2018 | Prague 9, Czech Republic | Drugs | Voluntary Action Indicated (VAI) | 3006712025 |
| May 22, 2013 | Prague 9, Czech Republic | Drugs | No Action Indicated (NAI) | 3006712025 |
| Jun 5, 2009 | Prague 9, Czech Republic | Drugs | Voluntary Action Indicated (VAI) | 3006712025 |
- 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 3006712025 | Prague 9, Czech Republic | 5 | Apr 25, 2025 |
| FEI 3014498434 | Prague 9, Czech Republic | 1 | Feb 29, 2024 |
ALS Czech Republic, S.R.O. and the FDA: common questions
Has ALS Czech Republic, S.R.O. received an FDA warning letter?
No FDA warning letter addressed to the name "ALS Czech Republic, 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 ALS Czech Republic, S.R.O. received an FDA Form 483?
FDA has not published a Form 483 for "ALS Czech Republic, S.R.O." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect ALS Czech Republic, S.R.O.?
The most recent FDA inspection on file ended Apr 25, 2025 at Prague 9, Czech Republic and was classified VAI. FDA has 6 inspections of ALS Czech Republic, S.R.O. on file.
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