Olon S.P.A. FDA Record
Olon S.P.A. has 0 FDA recalls, 47 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Olon S.P.A." is on file.
- Latest inspection
- Jan 16, 2026 · 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 | 47 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 5 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 6 | 0 | 0 | 0 | 0 |
| 2018 | 5 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 16, 2026 | Casaletto Lodigiano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808159 |
| Apr 11, 2025 | Settimo Torinese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806373 |
| Mar 28, 2025 | Rodano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002716636 |
| May 24, 2024 | Capua, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807048 |
| Jul 13, 2023 | Garbagnate Milanese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807440 |
| Mar 3, 2023 | Segrate, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807457 |
| Feb 16, 2023 | Mulazzano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808211 |
| Feb 10, 2023 | Garessio, Italy | Drugs | Voluntary Action Indicated (VAI) | 3003677897 |
| Feb 9, 2023 | Dorno, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009407861 |
| Oct 1, 2021 | Settimo Torinese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806373 |
| Jan 24, 2020 | Mulazzano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808211 |
| Oct 17, 2019 | Garessio, Italy | Drugs | Voluntary Action Indicated (VAI) | 3003677897 |
| Aug 9, 2019 | Garbagnate Milanese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807440 |
| Aug 2, 2019 | Casaletto Lodigiano, Italy | Drugs | No Action Indicated (NAI) | 3002808159 |
| Jul 25, 2019 | Dorno, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009407861 |
| May 24, 2019 | Rodano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002716636 |
| Apr 11, 2019 | Capua, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807048 |
| Sep 14, 2018 | Settimo Torinese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806373 |
| May 23, 2018 | Dorno, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009407861 |
| May 18, 2018 | Mulazzano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808211 |
- 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 3002808159 | Casaletto Lodigiano, Italy | 5 | Jan 16, 2026 |
| FEI 3002806373 | Settimo Torinese, Italy | 5 | Apr 11, 2025 |
| FEI 3002716636 | Rodano, Italy | 6 | Mar 28, 2025 |
| FEI 3002807048 | Capua, Italy | 5 | May 24, 2024 |
| FEI 3002807440 | Garbagnate Milanese, Italy | 4 | Jul 13, 2023 |
| FEI 3002807457 | Segrate, Italy | 5 | Mar 3, 2023 |
| FEI 3002808211 | Mulazzano, Italy | 7 | Feb 16, 2023 |
| FEI 3003677897 | Garessio, Italy | 5 | Feb 10, 2023 |
| FEI 3009407861 | Dorno, Italy | 5 | Feb 9, 2023 |
Olon S.P.A. and the FDA: common questions
Has Olon S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Olon S.P.A." 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 Olon S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "Olon S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Olon S.P.A.?
The most recent FDA inspection on file ended Jan 16, 2026 at Casaletto Lodigiano, Italy and was classified VAI. FDA has 47 inspections of Olon S.P.A. on file.
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