CellEra LLC
FDA Regulatory Profile
CellEra LLC has 6 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-0804-2022 · Class III · Dec 15, 2021
- Latest inspection
- Apr 14, 2022 · VAI
Reviewing CellEra LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check CellEra LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | 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 | 3 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0804-2022 | Class III | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box | Dec 15, 2021 |
| Z-0805-2022 | Class III | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box | Dec 15, 2021 |
| Z-0801-2022 | Class III | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | Dec 15, 2021 |
| Z-0803-2022 | Class III | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box | Dec 15, 2021 |
| Z-0802-2022 | Class III | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box | Dec 15, 2021 |
| Z-2085-2019 | Class II | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 | Sep 1, 2016 |
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3007594734 | Monroe, OH | 3 | Apr 14, 2022 |