IDT Australia Ltd.

CLOSEOUT LETTER IDT Australia Ltd. MARCS-CMS 547605 — August 27, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3000219354 Product: Drugs Recipient: Recipient Name Dr. David Sparling Recipient Title CEO IDT Australia Ltd. 45 Wadhurst Drive Boronia VIC 3155 Australia Issuing Office: Center for Drug Evaluation and Research 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Dr. Sparling: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-18-55 dated May 23, 2018. Based on our evaluation, it appears that you have addressed the violations and 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 violations and deviations be observed during a subsequent inspection or through other means. Sincerely. /S/ Bryce A. Hammer Compliance Officer Division of Drug Quality II Content current as of: 09/09/2019 Regulated Product(s) Drugs