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Dear Dr. Renninger:

The United States Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER-22-001 dated February 10, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or other applicable law.

Sincerely,
/S/
Melissa J. Mendoza, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

cc: Anne E. Johnson, Director
FDA ORA-BIMO East