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Based on limited metadata, Surgenex LLC, a biologics manufacturer, received an FDA Warning Letter on November 15, 2021, indicating significant compliance concerns with their biologic products or manufacturing practices. Without access to the full letter text or detailed subject information, the specific nature of the violations cannot be determined from the available metadata alone. The warning was issued through FDA channels overseeing biologic products, which typically regulate vaccines, blood products, cellular/gene therapies, and other biological medicines. To understand the complete regulatory issues and required corrective actions, review of the full Warning Letter document would be necessary.