# FDA 483 - Nascent Surgical, LLC - February 23, 2026

Source: https://www.keypedia.com/records/483/nascent-surgical-llc/1aefc4ec-d1e6-4643-9fac-a31888c34fce

> FDA 483 for Nascent Surgical, LLC on February 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nascent Surgical, LLC
- Inspection Date: 2026-02-23
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: SurgiSmoke Solutions, a medical device firm in Saint Paul, MN, received an FDA Form 483 citing significant quality system deficiencies. The inspection revealed inadequate design validation for its smoke capture device, including failed shelf-life testing and distribution of potentially compromised sterile products. Additionally, the firm failed to perform required sterility assurance audits and did not adequately document or implement corrective actions, indicating a breakdown in quality management, especially during a management transition.

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/nascent-surgical-llc/87516d60-7d5a-42cf-aa5b-42f9e3ccf8ba

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d