Marcus Research Laboratory, Inc.

CLOSEOUT LETTER Marcus Research Laboratory, Inc. MARCS-CMS 615153 — October 02, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1950348 Product: Drugs Recipient: Recipient Name Mr. Richard A. Gilbert Recipient Title President Marcus Research Laboratory, Inc. 1820 Delmar Blvd. St. Louis , MO 63103 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Gilbert: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #615153 dated September 30, 2021. Based on our evaluation, it appears that you have addressed the deviations 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 assure 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Christopher Keating Compliance Officer Division of Drug Quality II Content current as of: 10/04/2024 Regulated Product(s) Drugs