PRO-TECH Design & Mfg., Inc.
FDA Regulatory Profile
PRO-TECH Design & Mfg., Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Apr 14, 2025 · VAI
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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 | 0 | 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 |
|---|
| Apr 14, 2025 | Arlington, TX | Devices | Voluntary Action Indicated (VAI) | 3010531069 |
| Mar 28, 2022 | Arlington, TX | Devices | No Action Indicated (NAI) | 3010531069 |
| Jan 25, 2018 | Arlington, TX | Devices | No Action Indicated (NAI) | 3010531069 |
| Feb 29, 2016 | Arlington, TX | Devices | No Action Indicated (NAI) | 3010531069 |
| Dec 11, 2014 | Arlington, TX | Devices | No Action Indicated (NAI) | 3010531069 |
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 3010531069 | Arlington, TX | 5 | Apr 14, 2025 |