Toxikon Corporation/Labcorp Bedford LLC

CLOSEOUT LETTER Toxikon Corporation/Labcorp Bedford LLC MARCS-CMS 623581 — October 25, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Biologics Recipient: Recipient Name Matthew Renninger, DVM, PhD Recipient Title Vice President Toxikon Corporation/Labcorp Bedford LLC Toxikon Corporation 15 Wiggins Avenue Bedford , MA 01730-2314 United States Issuing Office: Center for Biologics Evaluation and Research United States 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 Content current as of: 11/02/2022 Regulated Product(s) Biologics