Baxter R & D Europe FDA Record
Baxter R & D Europe has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Baxter R & D Europe" is on file.
- Latest recall
- Z-0151-2027 · Sep 14, 2026 · filed under Baxter Healthcare Corporation
- Latest inspection
- Feb 2, 2023 · VAI
Newer recall under related name Baxter Healthcare Corporation: Sep 14, 2026, Z-0151-2027.
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 | 2 | 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 |
|---|---|---|---|---|
| Feb 2, 2023 | Braine-L'Alleud, Belgium | Drugs | Voluntary Action Indicated (VAI) | 1000359047 |
| Jun 21, 2013 | Braine-L'Alleud, Belgium | Biologics | No Action Indicated (NAI) | 1000359047 |
- 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 1000359047 | Braine-L'Alleud, Belgium | 2 | Feb 2, 2023 |
Baxter R & D Europe and the FDA: common questions
Has Baxter R & D Europe received an FDA warning letter?
No FDA warning letter addressed to the name "Baxter R & D Europe" 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 Baxter R & D Europe received an FDA Form 483?
FDA has not published a Form 483 for "Baxter R & D Europe" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Baxter R & D Europe?
The most recent FDA inspection on file ended Feb 2, 2023 at Braine-L'Alleud, Belgium and was classified VAI. FDA has 2 inspections of Baxter R & D Europe on file.
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