# FDA 483 - CNS Vital Signs, LLC. - April 17, 2025

Source: https://www.globalkeysolutions.net/records/483/cns-vital-signs-llc/62c60cfa-7cdb-4358-91fa-4dad9e56862c

> FDA 483 for CNS Vital Signs, LLC. on April 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CNS Vital Signs, LLC.
- Inspection Date: 2025-04-17
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of CNS Vital Signs, LLC. in Morrisville, NC, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for corrective and preventive actions, complaint handling, medical device reporting, quality audits, and management review. These findings indicate a fundamental lack of a robust quality system.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/cns-vital-signs-llc/12bcd853-a57b-47a5-b2c0-38b9dcf3e49b

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7