ImmuCell Corporation
FDA Regulatory Profile
ImmuCell Corporation has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jan 23, 2024 · VAI
- Latest 510(k)
- Aug 3, 1984
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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 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | 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 |
|---|
| Jan 23, 2024 | Portland, ME | Veterinary | Voluntary Action Indicated (VAI) | 1000086700 |
| Mar 29, 2022 | Portland, ME | Veterinary | Official Action Indicated (OAI) | 1000086700 |
| Sep 20, 2019 | Portland, ME | Veterinary | Official Action Indicated (OAI) | 1000086700 |
| Sep 17, 2018 | Portland, ME | Veterinary | Voluntary Action Indicated (VAI) | 1000086700 |
| Sep 23, 2016 | Portland, ME | Veterinary | Voluntary Action Indicated (VAI) | 1000086700 |
| Apr 11, 2013 | Portland, ME | Veterinary | Voluntary Action Indicated (VAI) | 1000086700 |
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 1000086700 | Portland, ME | 6 | Jan 23, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K842709 | IMMUSTAPH LATEX AGGLUTINATION KIT | Aug 3, 1984 |