Amy Lightner MD

CLOSEOUT LETTER Amy Lightner MD MARCS-CMS 682593 — May 06, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Biologics Recipient: Recipient Name Amy Lightner, MD Amy Lightner MD (b)(6) United States (b)(6) Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices United States Dear Dr. Lightner: The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-25-682593 dated March 25, 2025. 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 from your responsibility to take all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The Agency expects you to continuously comply with the law and will monitor your state of compliance. Sincerely, /S/ Melissa J. Mendoza, JD Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Content current as of: 06/03/2025 Regulated Product(s) Biologics