Minakem Dunkerque Production FDA Record
Minakem Dunkerque Production has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Minakem Dunkerque Production" is on file.
- Latest inspection
- May 21, 2021 · 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 21, 2021 | Dunkirk, France | Drugs | Voluntary Action Indicated (VAI) | 3008093605 |
| Jun 22, 2018 | Dunkirk, France | Drugs | Voluntary Action Indicated (VAI) | 3008093605 |
| Apr 22, 2016 | Dunkirk, France | Drugs | Voluntary Action Indicated (VAI) | 3008093605 |
| May 17, 2013 | Dunkirk, France | Drugs | No Action Indicated (NAI) | 3008093605 |
- 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 3008093605 | Dunkirk, France | 4 | May 21, 2021 |
Minakem Dunkerque Production and the FDA: common questions
Has Minakem Dunkerque Production received an FDA warning letter?
No FDA warning letter addressed to the name "Minakem Dunkerque Production" 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 Minakem Dunkerque Production received an FDA Form 483?
FDA has not published a Form 483 for "Minakem Dunkerque Production" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Minakem Dunkerque Production?
The most recent FDA inspection on file ended May 21, 2021 at Dunkirk, France and was classified VAI. FDA has 4 inspections of Minakem Dunkerque Production on file.
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