Molex, Inc. FDA Record
Molex, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Molex, Inc." is on file.
- Latest inspection
- Apr 16, 2025 · NAI
- Latest 510(k)
- Jun 30, 2004
Summary
| 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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 16, 2025 | Maumelle, AR | Devices | No Action Indicated (NAI) | 3011397539 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011397539 | Maumelle, AR | 1 | Apr 16, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K040663 | TELENABLE EMS SYSTEM | Jun 30, 2004 |
Molex, Inc. and the FDA: common questions
Has Molex, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Molex, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Molex, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Molex, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Molex, Inc.?
The most recent FDA inspection on file ended Apr 16, 2025 at Maumelle, AR and was classified NAI. FDA has 1 inspection of Molex, Inc. on file.
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