SanaVita Medical, LLC FDA Record
- Latest inspection NAI · Nov 19, 2021
- No warning letters matched by name
SanaVita Medical, LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SanaVita Medical, LLC" is on file.
- Latest inspection
- Nov 19, 2021 · NAI
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 |
|---|---|---|---|---|
| Nov 19, 2021 | Telford, PA | Devices | No Action Indicated (NAI) | 3013378907 |
- 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 3013378907 | Telford, PA | 1 | Nov 19, 2021 |
SanaVita Medical, LLC and the FDA: common questions
Has SanaVita Medical, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "SanaVita 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 SanaVita Medical, LLC received an FDA Form 483?
FDA has not published a Form 483 for "SanaVita Medical, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SanaVita Medical, LLC?
The most recent FDA inspection on file ended Nov 19, 2021 at Telford, PA and was classified NAI. FDA has 1 inspection of SanaVita Medical, LLC on file.
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