Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. FDA Record
- Latest inspection VAI · Nov 21, 2024
- No warning letters matched by name
Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Istituto Biochimico Italiano Giovanni Lorenzini S.P.A." is on file.
- Latest inspection
- Nov 21, 2024 · 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 | 8 | 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
Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 1 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 21, 2024 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Sep 19, 2023 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Feb 21, 2020 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Jul 17, 2018 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Jul 4, 2017 | Aprilia, Italy | Drugs | Official Action Indicated (OAI) | 3002807242 |
| Mar 3, 2015 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Oct 5, 2012 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
| Oct 30, 2009 | Aprilia, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807242 |
- 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 3002807242 | Aprilia, Italy | 8 | Nov 21, 2024 |
Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. and the FDA: common questions
Has Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Istituto Biochimico Italiano Giovanni Lorenzini 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 Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "Istituto Biochimico Italiano Giovanni Lorenzini S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.?
The most recent FDA inspection on file ended Nov 21, 2024 at Aprilia, Italy and was classified VAI. FDA has 8 inspections of Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. on file, 1 of them classified OAI (official action indicated).
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