CNS Vital Signs, LLC. FDA Record
CNS Vital Signs, LLC. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CNS Vital Signs, LLC." is on file.
- Latest inspection
- Apr 17, 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 17, 2025 | Morrisville, NC | Devices | Voluntary Action Indicated (VAI) | 3006559064 |
- 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 3006559064 | Morrisville, NC | 1 | Apr 17, 2025 |
CNS Vital Signs, LLC. and the FDA: common questions
Has CNS Vital Signs, LLC. received an FDA warning letter?
No FDA warning letter addressed to the name "CNS Vital Signs, 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 CNS Vital Signs, LLC. received an FDA Form 483?
FDA has not published a Form 483 for "CNS Vital Signs, LLC." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CNS Vital Signs, LLC.?
The most recent FDA inspection on file ended Apr 17, 2025 at Morrisville, NC and was classified VAI. FDA has 1 inspection of CNS Vital Signs, LLC. on file.
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