FIS - Fabbrica Italiana Sintetici S.P.A. FDA Record
- Latest inspection VAI · Mar 6, 2026
- No warning letters matched by name
FIS - Fabbrica Italiana Sintetici S.P.A. has 0 FDA recalls, 18 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "FIS - Fabbrica Italiana Sintetici S.P.A." is on file.
- Latest inspection
- Mar 6, 2026 · VAI
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 | 18 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
FIS - Fabbrica Italiana Sintetici S.P.A.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 2 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 6, 2026 | Montecchio Maggiore, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806961 |
| May 17, 2024 | Montecchio Maggiore, Italy | Veterinary | No Action Indicated (NAI) | 3002806961 |
| Sep 22, 2023 | Termoli, Italy | Drugs | Voluntary Action Indicated (VAI) | 3008347496 |
| Oct 28, 2022 | Lonigo, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808541 |
| May 6, 2022 | Montecchio Maggiore, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806961 |
| Sep 17, 2021 | Termoli, Italy | Drugs | Voluntary Action Indicated (VAI) | 3008347496 |
| Jul 5, 2019 | Lonigo, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808541 |
| Jul 6, 2018 | Montecchio Maggiore, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806961 |
| Jun 1, 2018 | Termoli, Italy | Drugs | Voluntary Action Indicated (VAI) | 3008347496 |
| Feb 17, 2017 | Montecchio Maggiore, Italy | Drugs | No Action Indicated (NAI) | 3002806961 |
| Feb 25, 2016 | Lonigo, Italy | Drugs | No Action Indicated (NAI) | 3002808541 |
| May 29, 2015 | Termoli, Italy | Drugs | No Action Indicated (NAI) | 3008347496 |
| Apr 23, 2015 | Montecchio Maggiore, Italy | Drugs | No Action Indicated (NAI) | 3002806961 |
| Feb 7, 2013 | Lonigo, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002808541 |
| Apr 5, 2012 | Termoli, Italy | Drugs | No Action Indicated (NAI) | 3008347496 |
| Mar 29, 2012 | Montecchio Maggiore, Italy | Drugs | No Action Indicated (NAI) | 3002806961 |
| Jan 22, 2010 | Lonigo, Italy | Drugs | No Action Indicated (NAI) | 3002808541 |
| Apr 24, 2009 | Montecchio Maggiore, Italy | Veterinary | No Action Indicated (NAI) | 3002806961 |
- 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 3002806961 | Montecchio Maggiore, Italy | 8 | Mar 6, 2026 |
| FEI 3008347496 | Termoli, Italy | 5 | Sep 22, 2023 |
| FEI 3002808541 | Lonigo, Italy | 5 | Oct 28, 2022 |
FIS - Fabbrica Italiana Sintetici S.P.A. and the FDA: common questions
Has FIS - Fabbrica Italiana Sintetici S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "FIS - Fabbrica Italiana Sintetici 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 FIS - Fabbrica Italiana Sintetici S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "FIS - Fabbrica Italiana Sintetici S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect FIS - Fabbrica Italiana Sintetici S.P.A.?
The most recent FDA inspection on file ended Mar 6, 2026 at Montecchio Maggiore, Italy and was classified VAI. FDA has 18 inspections of FIS - Fabbrica Italiana Sintetici S.P.A. on file.
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