NerPharMa S.R.L. FDA Record
NerPharMa S.R.L. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "NerPharMa S.R.L." is on file. FDA has published 1 Form 483 for NerPharMa S.R.L..
- Latest inspection
- Sep 13, 2024 · VAI
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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 | 7 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
NerPharMa S.R.L. Form 483s
| Date | Document | FEI |
|---|---|---|
| Jun 27, 2025 | 483 | 3004762406 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 13, 2024 | Nerviano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3004762406 |
| Jan 17, 2020 | Nerviano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3004762406 |
| Jun 1, 2017 | Nerviano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3004762406 |
| Mar 5, 2015 | Nerviano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3004762406 |
| Dec 12, 2012 | Nerviano, Italy | Drugs | No Action Indicated (NAI) | 3004762406 |
| Jul 19, 2010 | Nerviano, Italy | Drugs | No Action Indicated (NAI) | 3004762406 |
| Oct 30, 2009 | Nerviano, Italy | Drugs | Voluntary Action Indicated (VAI) | 3004762406 |
- 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 3004762406 | Nerviano, Italy | 7 | Sep 13, 2024 |
NerPharMa S.R.L. and the FDA: common questions
Has NerPharMa S.R.L. received an FDA warning letter?
No FDA warning letter addressed to the name "NerPharMa S.R.L." 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 NerPharMa S.R.L. received an FDA Form 483?
FDA has published 1 Form 483 for NerPharMa S.R.L. in its reading room, the most recent dated Jun 27, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect NerPharMa S.R.L.?
The most recent FDA inspection on file ended Sep 13, 2024 at Nerviano, Italy and was classified VAI. FDA has 7 inspections of NerPharMa S.R.L. on file.
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