GelCool Systems, Inc FDA Record
- Latest inspection VAI · Mar 7, 2016
- No warning letters matched by name
GelCool Systems, Inc has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GelCool Systems, Inc" is on file.
- Latest inspection
- Mar 7, 2016 · VAI
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 | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 7, 2016 | Franklin, TN | Devices | Voluntary Action Indicated (VAI) | 3010877629 |
- 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 3010877629 | Franklin, TN | 1 | Mar 7, 2016 |
GelCool Systems, Inc and the FDA: common questions
Has GelCool Systems, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "GelCool Systems, 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 GelCool Systems, Inc received an FDA Form 483?
FDA has not published a Form 483 for "GelCool Systems, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GelCool Systems, Inc?
The most recent FDA inspection on file ended Mar 7, 2016 at Franklin, TN and was classified VAI. FDA has 1 inspection of GelCool Systems, Inc on file.
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