Beltapharm SPA FDA Record
Beltapharm SPA has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Beltapharm SPA" is on file.
- Latest inspection
- Jul 14, 2023 · 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 | 4 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 14, 2023 | Cusano Milanino, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009853808 |
| Mar 29, 2019 | Cusano Milanino, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009853808 |
| May 15, 2015 | Cusano Milanino, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009853808 |
| Jun 14, 2013 | Cusano Milanino, Italy | Drugs | Voluntary Action Indicated (VAI) | 3009853808 |
- 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 3009853808 | Cusano Milanino, Italy | 4 | Jul 14, 2023 |
Beltapharm SPA and the FDA: common questions
Has Beltapharm SPA received an FDA warning letter?
No FDA warning letter addressed to the name "Beltapharm SPA" 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 Beltapharm SPA received an FDA Form 483?
FDA has not published a Form 483 for "Beltapharm SPA" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Beltapharm SPA?
The most recent FDA inspection on file ended Jul 14, 2023 at Cusano Milanino, Italy and was classified VAI. FDA has 4 inspections of Beltapharm SPA on file.
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