Genesis Biologics, Inc.
Genesis Biologics, Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 20, 2025 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 20, 2025 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3008066433 |
| Jul 21, 2023 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3008066433 |
| Jun 26, 2018 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3008066433 |
| Dec 10, 2014 | Irvine, CA | Biologics | No Action Indicated (NAI) | 3008066433 |
| May 25, 2012 | Irvine, CA | Biologics | Voluntary Action Indicated (VAI) | 3008066433 |
| Jan 27, 2010 | Newbury Park, CA | Biologics | Voluntary Action Indicated (VAI) | 3007793345 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008066433 | Irvine, CA | 5 | Nov 20, 2025 |
| FEI 3007793345 | Newbury Park, CA | 1 | Jan 27, 2010 |