Professional Disposables International, Inc.

CLOSEOUT LETTER Professional Disposables International, Inc. MARCS-CMS 617201 — December 05, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 2411192 Product: Drugs Recipient: Recipient Name Mr. Zachary Julius Recipient Title CEO Professional Disposables International, Inc. 4855 Pine Tree Drive Miami Beach , FL 33140 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States Secondary Issuing Offices United States Dear Mr. Julius: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 617201 dated January 07, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to Professional Disposables International, Inc., FEI 2411192. 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 violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Emmanuel Ramos Compliance Officer Division of Drug Quality III Office of Manufacturing Quality Content current as of: 12/12/2024 Regulated Product(s) Drugs