Bayer Medical SRL FDA Record
Bayer Medical SRL has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bayer Medical SRL" is on file.
- Latest recall
- Z-3147-2026 · Jul 31, 2026 · filed under Bayer Medical Care
- Latest inspection
- Apr 16, 2015 · NAI
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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 16, 2015 | Heredia, Costa Rica | Devices | No Action Indicated (NAI) | 3011334555 |
- 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 3011334555 | Heredia, Costa Rica | 1 | Apr 16, 2015 |
Bayer Medical SRL and the FDA: common questions
Has Bayer Medical SRL received an FDA warning letter?
No FDA warning letter addressed to the name "Bayer Medical 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 Medical SRL received an FDA Form 483?
FDA has not published a Form 483 for "Bayer Medical SRL" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bayer Medical SRL?
The most recent FDA inspection on file ended Apr 16, 2015 at Heredia, Costa Rica and was classified NAI. FDA has 1 inspection of Bayer Medical SRL on file.
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