Eclipse Medcorp, LLC FDA Record
- Latest inspection VAI · Nov 9, 2018
- Last warning letter 2016
Eclipse Medcorp, LLC has 0 FDA recalls, 4 inspections, 4 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Eclipse Medcorp, LLC, the most recent on Mar 28, 2016.
- Latest inspection
- Nov 9, 2018 · VAI
- Latest 510(k)
- Oct 26, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 4 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 4 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Eclipse Medcorp, LLC FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 28, 2016 · Record page | |||
| Oct 27, 2015 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 9, 2018 | Lewisville, TX | Devices | Voluntary Action Indicated (VAI) | 3009032449 |
| Aug 5, 2016 | Lewisville, TX | Devices | Voluntary Action Indicated (VAI) | 3009032449 |
| Aug 13, 2015 | Lewisville, TX | Devices | Official Action Indicated (OAI) | 3009032449 |
| Dec 15, 2014 | Lewisville, TX | Devices | Official Action Indicated (OAI) | 3009032449 |
- 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.
Compliance Actions
FDA's compliance actions data lists 2 compliance actions under Eclipse Medcorp, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009032449 | Lewisville, TX | 4 | Nov 9, 2018 |
Eclipse Medcorp, LLC and the FDA: common questions
Has Eclipse Medcorp, LLC received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Eclipse Medcorp, LLC. The most recent is dated Mar 28, 2016.
Has Eclipse Medcorp, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Eclipse Medcorp, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Eclipse Medcorp, LLC?
The most recent FDA inspection on file ended Nov 9, 2018 at Lewisville, TX and was classified VAI. FDA has 4 inspections of Eclipse Medcorp, LLC on file, 2 of them classified OAI (official action indicated).
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