"MIRKO" SP. Z.O.O. FDA Record
"MIRKO" SP. Z.O.O. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to ""MIRKO" SP. Z.O.O." is on file.
- Latest inspection
- Jan 17, 2020 · VAI
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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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 17, 2020 | Slupsk, Poland | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3013031228 |
- 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 3013031228 | Slupsk, Poland | 1 | Jan 17, 2020 |
"MIRKO" SP. Z.O.O. and the FDA: common questions
Has "MIRKO" SP. Z.O.O. received an FDA warning letter?
No FDA warning letter addressed to the name ""MIRKO" SP. Z.O.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 "MIRKO" SP. Z.O.O. received an FDA Form 483?
FDA has not published a Form 483 for ""MIRKO" SP. Z.O.O." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect "MIRKO" SP. Z.O.O.?
The most recent FDA inspection on file ended Jan 17, 2020 at Slupsk, Poland and was classified VAI. FDA has 1 inspection of "MIRKO" SP. Z.O.O. on file.
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