Northeast Resins & Silicones, LLC
FDA Regulatory Profile
Northeast Resins & Silicones, LLC has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Aug 19, 2025 · NAI
- Latest 510(k)
- Jun 13, 2001
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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 | 5 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 19, 2025 | Southington, CT | Devices | No Action Indicated (NAI) | 3002649941 |
| Aug 16, 2022 | Southington, CT | Devices | No Action Indicated (NAI) | 3002649941 |
| Dec 13, 2016 | Southington, CT | Devices | No Action Indicated (NAI) | 3002649941 |
| Jun 18, 2013 | Southington, CT | Devices | Voluntary Action Indicated (VAI) | 3002649941 |
| Sep 10, 2009 | Southington, CT | Devices | Voluntary Action Indicated (VAI) | 3002649941 |
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 3002649941 | Southington, CT | 5 | Aug 19, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K011450 | SILICONE IMPRESSION MATERIAL | Jun 13, 2001 |