Bayer Healthcare Manufacturing Srl FDA Record
Bayer Healthcare Manufacturing Srl has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bayer Healthcare Manufacturing Srl" is on file.
- Latest recall
- Z-3147-2026 · Jul 31, 2026 · filed under Bayer Medical Care
- Latest inspection
- Jul 20, 2023 · 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 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 20, 2023 | Garbagnate Milanese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806461 |
| Apr 19, 2019 | Garbagnate Milanese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806461 |
| Oct 16, 2015 | Garbagnate Milanese, Italy | Drugs | No Action Indicated (NAI) | 3002806461 |
| Mar 15, 2013 | Garbagnate Milanese, Italy | Drugs | No Action Indicated (NAI) | 3002806461 |
| Apr 3, 2009 | Garbagnate Milanese, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002806461 |
- 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 3002806461 | Garbagnate Milanese, Italy | 5 | Jul 20, 2023 |
Bayer Healthcare Manufacturing Srl and the FDA: common questions
Has Bayer Healthcare Manufacturing Srl received an FDA warning letter?
No FDA warning letter addressed to the name "Bayer Healthcare Manufacturing Srl" 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 Healthcare Manufacturing Srl received an FDA Form 483?
FDA has not published a Form 483 for "Bayer Healthcare Manufacturing Srl" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bayer Healthcare Manufacturing Srl?
The most recent FDA inspection on file ended Jul 20, 2023 at Garbagnate Milanese, Italy and was classified VAI. FDA has 5 inspections of Bayer Healthcare Manufacturing Srl on file.
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