Unite Medical LLC FDA Record
Unite Medical LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Unite Medical LLC" is on file.
- Latest inspection
- Apr 16, 2025 · VAI
Summary
| 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 | 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 | Lithia Springs, GA | Devices | Voluntary Action Indicated (VAI) | 3015727296 |
- 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 3015727296 | Lithia Springs, GA | 1 | Apr 16, 2025 |
Unite Medical LLC and the FDA: common questions
Has Unite Medical LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Unite Medical LLC" 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 Unite Medical LLC received an FDA Form 483?
FDA has not published a Form 483 for "Unite Medical LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Unite Medical LLC?
The most recent FDA inspection on file ended Apr 16, 2025 at Lithia Springs, GA and was classified VAI. FDA has 1 inspection of Unite Medical LLC on file.
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