Quality CDMO, Inc.

CLOSEOUT LETTER Quality CDMO, Inc. MARCS-CMS 665961 — May 01, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Anin Shakiba Recipient Title President Quality CDMO, Inc. 5000 South Freeway, Suite 106 Fort Worth , TX 76115 United States a.shakiba@qcdmo.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Shakiba: The U.S. Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 665961) dated September 11, 2024. 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 with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Content current as of: 05/11/2026 Regulated Product(s) Drugs