Bayer De Mexico, S.A De C.V FDA Record
Bayer De Mexico, S.A De C.V has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bayer De Mexico, S.A De C.V" is on file.
- Latest recall
- Z-3147-2026 · Jul 31, 2026 · filed under Bayer Medical Care
- Latest inspection
- Jun 5, 2026 · VAI
Newer recall under related name Bayer Medical Care: Jul 31, 2026, Z-3147-2026.
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 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|---|
| Jun 5, 2026 | Ixtaczoquitlan, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3002807925 |
| Dec 9, 2022 | Lerma, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3002806479 |
| Jan 25, 2019 | Ixtaczoquitlan, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3002807925 |
| May 11, 2018 | Lerma, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3002806479 |
| Oct 23, 2015 | Lerma, Mexico | Drugs | Voluntary Action Indicated (VAI) | 3002806479 |
| Feb 14, 2014 | Ixtaczoquitlan, Mexico | Drugs | No Action Indicated (NAI) | 3002807925 |
| Nov 5, 2010 | Ixtaczoquitlan, Mexico | Drugs | No Action Indicated (NAI) | 3002807925 |
- 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 3002807925 | Ixtaczoquitlan, Mexico | 4 | Jun 5, 2026 |
| FEI 3002806479 | Lerma, Mexico | 3 | Dec 9, 2022 |
Bayer De Mexico, S.A De C.V and the FDA: common questions
Has Bayer De Mexico, S.A De C.V received an FDA warning letter?
No FDA warning letter addressed to the name "Bayer De Mexico, S.A De C.V" 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 Bayer De Mexico, S.A De C.V received an FDA Form 483?
FDA has not published a Form 483 for "Bayer De Mexico, S.A De C.V" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bayer De Mexico, S.A De C.V?
The most recent FDA inspection on file ended Jun 5, 2026 at Ixtaczoquitlan, Mexico and was classified VAI. FDA has 7 inspections of Bayer De Mexico, S.A De C.V on file.
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