CEP Bio-Coat, LLC
CEP Bio-Coat, LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Oct 12, 2022 · VAI
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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 | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 12, 2022 | Farmington Hills, MI | Devices | Voluntary Action Indicated (VAI) | 3011277306 |
| Sep 29, 2020 | Farmington Hills, MI | Devices | Voluntary Action Indicated (VAI) | 3011277306 |
| Feb 15, 2019 | Farmington Hills, MI | Devices | Official Action Indicated (OAI) | 3011277306 |
| Mar 10, 2016 | Farmington Hills, MI | Devices | Voluntary Action Indicated (VAI) | 3011277306 |
| Apr 26, 2012 | Farmington Hills, MI | Devices | No Action Indicated (NAI) | 3011277306 |
| Jul 16, 2009 | Farmington Hills, MI | Devices | Voluntary Action Indicated (VAI) | 3011277306 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011277306 | Farmington Hills, MI | 6 | Oct 12, 2022 |