Custom Assemblies Inc
FDA Regulatory Profile
Custom Assemblies Inc has 1 FDA recall, 6 inspections, 1 510(k) clearance and 1 compliance action on record.
- Latest recall
- Z-3059-2017 · Class II · Jun 15, 2017
- Latest inspection
- Jul 24, 2025 · NAI
- Latest 510(k)
- Jan 4, 2000
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | 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 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3059-2017 | Class II | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a)… | Jun 15, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 24, 2025 | Pine Level, NC | Devices | No Action Indicated (NAI) | 3000718854 |
| Oct 6, 2022 | Pine Level, NC | Devices | No Action Indicated (NAI) | 3000718854 |
| Jul 19, 2019 | Pine Level, NC | Devices | Voluntary Action Indicated (VAI) | 3000718854 |
| Jul 31, 2017 | Pine Level, NC | Devices | Official Action Indicated (OAI) | 3000718854 |
| Aug 8, 2013 | Pine Level, NC | Devices | No Action Indicated (NAI) | 3000718854 |
| Sep 1, 2011 | Pine Level, NC | Devices | Official Action Indicated (OAI) | 3000718854 |
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 3000718854 | Pine Level, NC | 6 | Jul 24, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K993463 | INTRAVASCULAR ADMINISTRATION SET | Jan 4, 2000 |