Chiesi Farmaceutici S.P.A. FDA Record
Chiesi Farmaceutici S.P.A. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Chiesi Farmaceutici S.P.A." is on file.
- Latest inspection
- Sep 29, 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 | 5 | 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 | 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 |
|---|---|---|---|---|
| Sep 29, 2023 | Parma, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806655 |
| Nov 23, 2018 | Parma, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806655 |
| Jul 26, 2018 | Parma, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806655 |
| Jul 29, 2016 | Parma, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806655 |
| Jul 8, 2011 | Parma, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806655 |
- 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 3002806655 | Parma, Italy | 5 | Sep 29, 2023 |
Chiesi Farmaceutici S.P.A. and the FDA: common questions
Has Chiesi Farmaceutici S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Chiesi Farmaceutici 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 Chiesi Farmaceutici S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "Chiesi Farmaceutici S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Chiesi Farmaceutici S.P.A.?
The most recent FDA inspection on file ended Sep 29, 2023 at Parma, Italy and was classified VAI. FDA has 5 inspections of Chiesi Farmaceutici S.P.A. on file.
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