Unit Dose Services, LLC

CLOSEOUT LETTER Unit Dose Services, LLC MARCS-CMS 636177 — December 21, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: WL 2310 Product: Drugs Recipient: Recipient Name Peter Levasseur Unit Dose Services, LLC 20201 Northeast 16th Place Miami , FL 33179 United States Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Levasseur: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2310. Based on our evaluation, it appears that you have addressed the violations contained in this warning letter and corrected the data deficiencies. We have received an updated listing SPL with the correct carton label image for your product and an updated labeler code request SPL with the new contact information. Future FDA 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 Agency expects you and your firm to maintain compliance and to 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/ Carolyn E. Becker, JD 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: 12/27/2022 Regulated Product(s) Drugs