Warning Letter — NexCell Scientific Inc
The FDA issued a Warning Letter to NexCell Scientific Inc. on September 11, 2026, following an evaluation by the Center for Biologics Evaluation and Research (CBER).
NexCell Scientific Inc. and professionals responsible for regulatory compliance and quality assurance within biologics manufacturing organizations.
The involvement of CBER indicates potential non-compliance with regulations governing biological products. This action suggests that the firm's processes or products may have failed to meet specific safety, purity, or potency standards, or that there were significant deviations from administrative and clinical requirements.
Review current biologics manufacturing and clinical protocols against Center for Biologics Evaluation and Research (CBER) requirements. Ensure all documentation for investigational or commercial biological products is current and aligns with recent inspectional observations.
FDA Warning Letter issued to: NexCell Scientific Inc. 09/11/2026 — Center for Biologics Evaluation and Research. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nexcell-scientific-inc-730612-09112026
Open in openFDA / FDA.gov