Baitella AG
FDA Regulatory Profile
Baitella AG has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- May 15, 2025 · NAI
- Latest 510(k)
- Mar 22, 2007
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3001415205 | Zurich, Switzerland | 3 | May 15, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K070509 | FISSO HOLDING SYSTEM | Mar 22, 2007 |