Merck Sante FDA Record
Merck Sante has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Merck Sante" is on file.
- Latest inspection
- Oct 25, 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 | 11 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 3 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 25, 2024 | Semoy, France | Drugs | Voluntary Action Indicated (VAI) | 3002807504 |
| Sep 23, 2022 | Meyzieu, France | Drugs | Voluntary Action Indicated (VAI) | 3002807502 |
| Nov 17, 2021 | Calais, France | Drugs | Voluntary Action Indicated (VAI) | 3002807474 |
| Jul 19, 2018 | Calais, France | Drugs | No Action Indicated (NAI) | 3002807474 |
| Jul 11, 2018 | Meyzieu, France | Drugs | No Action Indicated (NAI) | 3002807502 |
| Jun 14, 2018 | Semoy, France | Drugs | No Action Indicated (NAI) | 3002807504 |
| Jun 21, 2016 | Semoy, France | Drugs | Voluntary Action Indicated (VAI) | 3002807504 |
| Jun 3, 2014 | Calais, France | Drugs | No Action Indicated (NAI) | 3002807474 |
| Apr 3, 2014 | Meyzieu, France | Drugs | Voluntary Action Indicated (VAI) | 3002807502 |
| Jun 17, 2013 | Semoy, France | Drugs | Voluntary Action Indicated (VAI) | 3002807504 |
| Apr 9, 2010 | Meyzieu, France | Drugs | No Action Indicated (NAI) | 3002807502 |
- 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 3002807504 | Semoy, France | 4 | Oct 25, 2024 |
| FEI 3002807502 | Meyzieu, France | 4 | Sep 23, 2022 |
| FEI 3002807474 | Calais, France | 3 | Nov 17, 2021 |
Merck Sante and the FDA: common questions
Has Merck Sante received an FDA warning letter?
No FDA warning letter addressed to the name "Merck Sante" 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 Merck Sante received an FDA Form 483?
FDA has not published a Form 483 for "Merck Sante" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Merck Sante?
The most recent FDA inspection on file ended Oct 25, 2024 at Semoy, France and was classified VAI. FDA has 11 inspections of Merck Sante on file.
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