Metro Optics, Inc. FDA Record
Metro Optics, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Metro Optics, Inc." is on file.
- Latest inspection
- Mar 17, 2025 · NAI
- Latest 510(k)
- Feb 12, 2003
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 | 3 | 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 |
|---|---|---|---|---|
| Mar 17, 2025 | Dallas, TX | Devices | No Action Indicated (NAI) | 3012428549 |
| Aug 7, 2014 | Dallas, TX | Devices | Voluntary Action Indicated (VAI) | 3012428549 |
| Dec 28, 2011 | Dallas, TX | Devices | No Action Indicated (NAI) | 3012428549 |
- 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 3012428549 | Dallas, TX | 3 | Mar 17, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K024164 | COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP)… | Feb 12, 2003 |
Metro Optics, Inc. and the FDA: common questions
Has Metro Optics, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Metro Optics, 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 Metro Optics, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Metro Optics, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Metro Optics, Inc.?
The most recent FDA inspection on file ended Mar 17, 2025 at Dallas, TX and was classified NAI. FDA has 3 inspections of Metro Optics, Inc. on file.
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