Bioindustria Laboratorio Italiano Medicinali S.P.A FDA Record
- Latest inspection VAI · Jul 25, 2025
- No warning letters matched by name
Bioindustria Laboratorio Italiano Medicinali S.P.A has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bioindustria Laboratorio Italiano Medicinali S.P.A" is on file.
- Latest inspection
- Jul 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 | 9 | 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
Bioindustria Laboratorio Italiano Medicinali S.P.A: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 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 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 25, 2025 | Novi Ligure, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002717526 |
| Feb 24, 2023 | Novi Ligure, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002717526 |
| Apr 1, 2022 | Fresonara, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806499 |
| Jun 21, 2018 | Fresonara, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806499 |
| Jun 15, 2018 | Novi Ligure, Italy | Drugs | No Action Indicated (NAI) | 3002717526 |
| Mar 10, 2015 | Novi Ligure, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002717526 |
| Sep 18, 2014 | Fresonara, Italy | Drugs | No Action Indicated (NAI) | 3002806499 |
| Jun 25, 2013 | Novi Ligure, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002717526 |
| Apr 7, 2011 | Fresonara, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806499 |
- 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 3002717526 | Novi Ligure, Italy | 5 | Jul 25, 2025 |
| FEI 3002806499 | Fresonara, Italy | 4 | Apr 1, 2022 |
Bioindustria Laboratorio Italiano Medicinali S.P.A and the FDA: common questions
Has Bioindustria Laboratorio Italiano Medicinali S.P.A received an FDA warning letter?
No FDA warning letter addressed to the name "Bioindustria Laboratorio Italiano Medicinali 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 Bioindustria Laboratorio Italiano Medicinali S.P.A received an FDA Form 483?
FDA has not published a Form 483 for "Bioindustria Laboratorio Italiano Medicinali S.P.A" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bioindustria Laboratorio Italiano Medicinali S.P.A?
The most recent FDA inspection on file ended Jul 25, 2025 at Novi Ligure, Italy and was classified VAI. FDA has 9 inspections of Bioindustria Laboratorio Italiano Medicinali S.P.A on file.
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