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

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.